Trial Outcomes & Findings for Evaluation Of An Advanced Borderless Dressing (NCT NCT03146845)
NCT ID: NCT03146845
Last Updated: 2023-05-10
Results Overview
The primary objective was to estimate the effect of treatment with ALLEVYN Life Non-Bordered (ALNB) on Health-Related Quality of Life (HRQoL) in subjects with chronic ulcers, measured using the CWIS-PSDL scale, compared to subjects receiving standard care (SC) alone over a 6-week treatment period. The CWIS is a questionnaire to measure the impact of chronic wounds on patient health-related quality of life and identify areas of patient concern. The CWIS-PSDL score is transformed on to a 0-100 scale, where a high score indicates a positive rating. The following calculation is used: CWIS-PSDL = (Sum of PSDL item scores-N\_PSDL)/(N\_PSDL "x" 4) ×100, where NPSDL = count of 24 questions completed (experience and stress) PSDL Sub-scores are based on 24 questions (12 items on the extent of the problem and 12 on the associated stress), each graded on a 5-point Likert scale \[1-5\]) with higher scores indicating a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline through 6 weeks
Results posted on
2023-05-10
Participant Flow
Participant milestones
| Measure |
ALLEVYN Life Non-Bordered
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
15
|
|
Overall Study
COMPLETED
|
20
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
ALLEVYN Life Non-Bordered
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Overall Study
Reference ulcer healed
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Noncompliance
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Surgeon applied a graft with non-removable dressing; discharged to surgeon's care
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ALLEVYN Life Non-Bordered
n=25 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=15 Participants
Standard care dressing
Standard Care: Foam Dressing
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 15.5 • n=25 Participants
|
53.7 years
STANDARD_DEVIATION 16.8 • n=15 Participants
|
57.5 years
STANDARD_DEVIATION 16.1 • n=40 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=25 Participants
|
6 Participants
n=15 Participants
|
12 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=25 Participants
|
9 Participants
n=15 Participants
|
28 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
15 participants
n=15 Participants
|
40 participants
n=40 Participants
|
|
Height
|
67.9 inches
STANDARD_DEVIATION 3.4 • n=25 Participants
|
69.0 inches
STANDARD_DEVIATION 4.1 • n=15 Participants
|
68.3 inches
STANDARD_DEVIATION 3.7 • n=40 Participants
|
|
Weight
|
194.2 pounds
STANDARD_DEVIATION 65.6 • n=25 Participants
|
230.5 pounds
STANDARD_DEVIATION 39.4 • n=15 Participants
|
207.8 pounds
STANDARD_DEVIATION 59.3 • n=40 Participants
|
|
Body Mass Index
|
29.6 kg/m^2
STANDARD_DEVIATION 9.4 • n=25 Participants
|
34.1 kg/m^2
STANDARD_DEVIATION 5.7 • n=15 Participants
|
31.3 kg/m^2
STANDARD_DEVIATION 8.4 • n=40 Participants
|
|
Reference Wound Type
Pressure ulcer
|
5 Participants
n=25 Participants
|
2 Participants
n=15 Participants
|
7 Participants
n=40 Participants
|
|
Reference Wound Type
Diabetic foot ulcer
|
12 Participants
n=25 Participants
|
8 Participants
n=15 Participants
|
20 Participants
n=40 Participants
|
|
Reference Wound Type
Venous leg ulcer
|
8 Participants
n=25 Participants
|
4 Participants
n=15 Participants
|
12 Participants
n=40 Participants
|
|
Reference Wound Type
Mixed etiology ulcer
|
0 Participants
n=25 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=40 Participants
|
|
Reference Wound Type
Other
|
0 Participants
n=25 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
|
Wound Duration
|
240.3 days
STANDARD_DEVIATION 166.6 • n=25 Participants
|
292.9 days
STANDARD_DEVIATION 275.1 • n=15 Participants
|
260.1 days
STANDARD_DEVIATION 211.9 • n=40 Participants
|
|
Wound Location
Head/neck
|
0 Participants
n=25 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
|
Wound Location
Shoulders
|
0 Participants
n=25 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
|
Wound Location
Upper arm
|
0 Participants
n=25 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
|
Wound Location
Lower arm
|
0 Participants
n=25 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
|
Wound Location
Wrist/hand
|
0 Participants
n=25 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
|
Wound Location
Chest
|
0 Participants
n=25 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
|
Wound Location
Abdomen
|
0 Participants
n=25 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
|
Wound Location
Back
|
0 Participants
n=25 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
|
Wound Location
Hips
|
0 Participants
n=25 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
|
Wound Location
Buttocks
|
1 Participants
n=25 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=40 Participants
|
|
Wound Location
Sacrum
|
0 Participants
n=25 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
|
Wound Location
Upper leg
|
0 Participants
n=25 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
|
Wound Location
Lower leg/knee
|
5 Participants
n=25 Participants
|
4 Participants
n=15 Participants
|
9 Participants
n=40 Participants
|
|
Wound Location
Ankle
|
3 Participants
n=25 Participants
|
1 Participants
n=15 Participants
|
4 Participants
n=40 Participants
|
|
Wound Location
Foot
|
12 Participants
n=25 Participants
|
8 Participants
n=15 Participants
|
20 Participants
n=40 Participants
|
|
Wound Location
Other
|
4 Participants
n=25 Participants
|
2 Participants
n=15 Participants
|
6 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline through 6 weeksPopulation: Scores were calculated for the full analysis set (FAS) population (all randomized subjects who received study treatment and attended at least 1 post-Baseline visit).
The primary objective was to estimate the effect of treatment with ALLEVYN Life Non-Bordered (ALNB) on Health-Related Quality of Life (HRQoL) in subjects with chronic ulcers, measured using the CWIS-PSDL scale, compared to subjects receiving standard care (SC) alone over a 6-week treatment period. The CWIS is a questionnaire to measure the impact of chronic wounds on patient health-related quality of life and identify areas of patient concern. The CWIS-PSDL score is transformed on to a 0-100 scale, where a high score indicates a positive rating. The following calculation is used: CWIS-PSDL = (Sum of PSDL item scores-N\_PSDL)/(N\_PSDL "x" 4) ×100, where NPSDL = count of 24 questions completed (experience and stress) PSDL Sub-scores are based on 24 questions (12 items on the extent of the problem and 12 on the associated stress), each graded on a 5-point Likert scale \[1-5\]) with higher scores indicating a better outcome.
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=25 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit
Baseline Assessment
|
54.3 score on a scale
Standard Deviation 27.5
|
54.0 score on a scale
Standard Deviation 34.5
|
|
Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit
Week 6 Visit Assessment
|
71.2 score on a scale
Standard Deviation 24.4
|
56.3 score on a scale
Standard Deviation 27.9
|
|
Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit
Change in CWIS-PSDL Scale Score
|
15.3 score on a scale
Standard Deviation 23.3
|
2.3 score on a scale
Standard Deviation 17.8
|
SECONDARY outcome
Timeframe: PSDL: baseline, 3 and 12 weeks; WB, SL, GQ, and SQ: baseline, 3, 6, and 12 weeksPopulation: Not all subjects participated in answering these questionnaire assessments.
Assessment of the change over time for the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Score at 3 and 12 weeks; CWIS-Well-Being (WB), CWIS-Social Life (SL), CWIS-Global Quality of Life (GQ), CWIS-Quality of Life Scales (SQ) at 3, 6, and 12 weeks. PSDL, SL, and WB sub-scores are based on 24 (score range 24-120), 14 (score range 14-70), and 7 (score range 7-35) questions, respectively; (each graded on a 5-point Likert scale \[1-5\]) Higher scores on all CWIS metrics indicate a better outcome. PSDL score = (sum of PSDL item scores - 24)/96 x 100 = calculated score of 0 to 100; e.g., 95-24/96 x 100 = 74 (of a possible 100) WB Score = (sum of WB item scores - 7)/28 x 100 = calculated score of 0 to 100 SL Score = (sum of SL item scores - 14)/56 x 100 = calculated score of 0 to 100 GQ Score = "How good is your quality of life" = score range 0 to 10 SQ Score = "How satisfied are you with your overall quality of life" = score range 0 to 10
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=24 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks
CWIS-PSDL Score Change at 3 Weeks
|
6.0 score on a scale
Standard Deviation 18.0
|
5.4 score on a scale
Standard Deviation 35.6
|
|
Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks
CWIS-PSDL Score Change at 12 Weeks
|
17.3 score on a scale
Standard Deviation 22.1
|
16.6 score on a scale
Standard Deviation 32.2
|
|
Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks
CWIS-WB Score Change at 3 Weeks
|
9.5 score on a scale
Standard Deviation 18.8
|
13.2 score on a scale
Standard Deviation 25.7
|
|
Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks
CWIS-WB Score Change at 6 Weeks
|
16.1 score on a scale
Standard Deviation 23.1
|
4.9 score on a scale
Standard Deviation 14.7
|
|
Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks
CWIS-WB Score Change at 12 Weeks
|
19.2 score on a scale
Standard Deviation 24.6
|
18.1 score on a scale
Standard Deviation 28.5
|
|
Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks
CWIS-SL Score Change at 3 Weeks
|
9.8 score on a scale
Standard Deviation 22.9
|
8.1 score on a scale
Standard Deviation 37.0
|
|
Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks
CWIS-SL Score Change at 6 Weeks
|
14.9 score on a scale
Standard Deviation 25.4
|
7.0 score on a scale
Standard Deviation 26.7
|
|
Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks
CWIS-SL Score Change at 12 Weeks
|
10.5 score on a scale
Standard Deviation 32.4
|
16.1 score on a scale
Standard Deviation 34.0
|
|
Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks
CWIS-GQ Change at 3 Weeks
|
-0.0 score on a scale
Standard Deviation 3.1
|
0.8 score on a scale
Standard Deviation 2.3
|
|
Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks
CWIS-GQ Change at 6 Weeks
|
0.5 score on a scale
Standard Deviation 2.5
|
0.7 score on a scale
Standard Deviation 2.3
|
|
Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks
CWIS-GQ Change at 12 Weeks
|
0.6 score on a scale
Standard Deviation 2.3
|
1.1 score on a scale
Standard Deviation 2.0
|
|
Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks
CWIS-SQ Change at 3 Weeks
|
0.1 score on a scale
Standard Deviation 3.2
|
1.1 score on a scale
Standard Deviation 2.5
|
|
Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks
CWIS-SQ Change at 6 Weeks
|
0.7 score on a scale
Standard Deviation 2.5
|
1.1 score on a scale
Standard Deviation 2.2
|
|
Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks
CWIS-SQ Change at 12 Weeks
|
0.4 score on a scale
Standard Deviation 2.3
|
0.8 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 6, and 12Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) for an overall wound score at each time point. The mBWAT score combined the sub-scores of mBWAT - a tool that has been in widespread use since the early 1990s. mBWAT scoring: There are 13 categories of assessment with item-level score range of 1 to 5 on a modified Likert scale. Each item is scored for the wound characteristic it describes where 1 indicates least severe and 5 indicates most severe with higher scores indicating a more severe wound status. Scores taken over a period of time can be used to track the progression of the wound healing process. Possible score range from 13 to 65 for the total score. The 13 sub-categories include: Size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, and epithelialization
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=25 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score
Baseline Score
|
19.8 score on a scale
Standard Deviation 3.2
|
20 score on a scale
Standard Deviation 4.2
|
|
Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score
Week 3 Score
|
18.5 score on a scale
Standard Deviation 2.8
|
19.4 score on a scale
Standard Deviation 4.4
|
|
Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score
Week 6 Score
|
17.3 score on a scale
Standard Deviation 3.9
|
17.0 score on a scale
Standard Deviation 2.9
|
|
Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score
Week 12 Score
|
16.4 score on a scale
Standard Deviation 3.7
|
17.4 score on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 6, and 12Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the type of wound exudate exhibited at each time point. The tool defines the types of exudate as follows: Bloody = thin, bright red Serosanguinous = thin, watery, pale red to pink Serous = thin, watery, clear Purulent = thin or thick, opaque tan to yellow Foul purulent = thick, opaque yellow to green with offensive odor
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=25 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · None
|
0 Participants
|
0 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Bloody
|
0 Participants
|
1 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Serosanguineous
|
12 Participants
|
7 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Serous
|
11 Participants
|
5 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Purulent
|
2 Participants
|
0 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · None
|
1 Participants
|
0 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Bloody
|
0 Participants
|
0 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Serosanguineous
|
16 Participants
|
7 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Serous
|
6 Participants
|
4 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Purulent
|
1 Participants
|
0 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · None
|
5 Participants
|
2 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Bloody
|
1 Participants
|
1 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Serosanguineous
|
9 Participants
|
3 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Serous
|
9 Participants
|
5 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Purulent
|
0 Participants
|
0 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · None
|
11 Participants
|
5 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Bloody
|
2 Participants
|
1 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Serosanguineous
|
9 Participants
|
2 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Serous
|
2 Participants
|
3 Participants
|
|
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Purulent
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 6, and 12Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the amount of wound exudate demonstrated at each time point. The tool gives the following category descriptions for amount of exudate: None = wound tissues dry Scant = wound tissues moist; no measurable exudate Small = wound tissues wet; moisture evenly distributed in wound; drainage involves \</=25% dressing Moderate = wound tissues saturated; drainage may or may not be evenly distributed in wound; drainage involves \>25% to \</=75% dressing Large = wound tissues bathed in fluid; drainage freely expressed; may or may not be evenly distributed in wound; drainage involves \>75% dressing The tool advises to use a transparent metric measuring guide with concentric circles divided into 4 pie-shaped quadrants to determine percentage of dressing involved with exudate.
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=25 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · None
|
0 Participants
|
0 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Scant, wound, moist but no observable exudate
|
0 Participants
|
0 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Small
|
0 Participants
|
0 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Moderate
|
21 Participants
|
11 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Large
|
4 Participants
|
2 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · None
|
1 Participants
|
0 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Scant, wound, moist but no observable exudate
|
1 Participants
|
1 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Small
|
11 Participants
|
3 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Moderate
|
7 Participants
|
5 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Large
|
4 Participants
|
2 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · None
|
5 Participants
|
2 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Scant, wound, moist but no observable exudate
|
2 Participants
|
2 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Small
|
7 Participants
|
2 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Moderate
|
6 Participants
|
4 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Large
|
4 Participants
|
1 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · None
|
11 Participants
|
5 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Scant, wound, moist but no observable exudate
|
1 Participants
|
1 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Small
|
6 Participants
|
1 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Moderate
|
3 Participants
|
4 Participants
|
|
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Large
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 6, and 12Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the extent (measurement) of wound undermining at each time point. The tool guidance is as follows: Assess by inserting a cotton-tipped applicator under the wound edge; Advance it as far as it will go without using undue force; Raise the tip of the applicator so it may be seen or felt on the surface of the skin; Mark the surface with a pen; Measure the distance from the mark on the skin to the edge of the wound; Continue process around the wound; Then use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-shaped quadrants to help determine percent of wound involved.
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=25 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · None present
|
19 Participants
|
11 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · <2 cm in any area
|
4 Participants
|
2 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · 2-4 cm involving <50% wound margins
|
2 Participants
|
0 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · 2-4 cm involving >50% wound margins
|
0 Participants
|
0 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · >4 cm or tunnelling in any area
|
0 Participants
|
0 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · None present
|
21 Participants
|
9 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · <2 cm in any area
|
3 Participants
|
2 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · 2-4 cm involving <50% wound margins
|
0 Participants
|
0 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · 2-4 cm involving >50% wound margins
|
0 Participants
|
0 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · >4 cm or tunnelling in any area
|
0 Participants
|
0 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · None present
|
23 Participants
|
11 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · <2 cm in any area
|
1 Participants
|
0 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · 2-4 cm involving <50% wound margins
|
0 Participants
|
0 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · 2-4 cm involving >50% wound margins
|
0 Participants
|
0 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · >4 cm or tunnelling in any area
|
0 Participants
|
0 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · None present
|
23 Participants
|
12 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · <2 cm in any area
|
1 Participants
|
0 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · 2-4 cm involving <50% wound margins
|
0 Participants
|
0 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · 2-4 cm involving >50% wound margins
|
0 Participants
|
0 Participants
|
|
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · >4 cm or tunnelling in any area
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 6, and 12Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for type (appearance) of necrotic tissue at each time point. The tool defines the categories of necrotic tissue type as follows: White/gray non-viable tissue = may appear prior to wound opening; skin surface is white or gray Non-adherent, yellow slough = thin, mucinous substance; scattered throughout wound bed; easily separated from wound tissue Loosely adherent, yellow slough = thick, stringy, clumps of debris; attached to wound tissue Adherent, soft, black eschar = soggy tissue; strongly attached to tissue in center or base of wound Firmly adherent, hard/black eschar = firm, crusty tissue; strongly attached to wound base and edges (like a hard scab)
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=25 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · None
|
19 Participants
|
10 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · White/grey nonviable tissue and/or nonadherent yellow slough
|
3 Participants
|
0 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Loosely adherent yellow slough
|
3 Participants
|
1 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Adherent, soft, black eschar
|
0 Participants
|
2 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Firmly adherent, hard, black eschar
|
0 Participants
|
0 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · None
|
18 Participants
|
8 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · White/grey nonviable tissue and/or nonadherent yellow slough
|
2 Participants
|
0 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Loosely adherent yellow slough
|
1 Participants
|
2 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Adherent, soft, black eschar
|
1 Participants
|
0 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Firmly adherent, hard, black eschar
|
1 Participants
|
1 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · None
|
18 Participants
|
10 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · White/grey nonviable tissue and/or nonadherent yellow slough
|
2 Participants
|
0 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Loosely adherent yellow slough
|
2 Participants
|
0 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Adherent, soft, black eschar
|
1 Participants
|
1 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Firmly adherent, hard, black eschar
|
0 Participants
|
0 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · None
|
18 Participants
|
10 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · White/grey nonviable tissue and/or nonadherent yellow slough
|
1 Participants
|
0 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Loosely adherent yellow slough
|
2 Participants
|
0 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Adherent, soft, black eschar
|
2 Participants
|
0 Participants
|
|
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Firmly adherent, hard, black eschar
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 6, and 12Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the amount of necrotic tissue observed during dressing change at each time point. The tool guidance is to use a transparent metric measuring guide with concentric circles divided into 4 pie-shaped quadrants to help determine percent of wound involved.
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=25 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · >50% to <75% of wound covered
|
0 Participants
|
0 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · >75% to 100% of wound covered
|
0 Participants
|
1 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · <25% of wound bed covered
|
4 Participants
|
0 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · 25% to 50% of wound covered
|
1 Participants
|
1 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · >50% to <75% of wound covered
|
0 Participants
|
0 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · >75% to 100% of wound covered
|
0 Participants
|
0 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · None
|
18 Participants
|
10 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · <25% of wound bed covered
|
4 Participants
|
0 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · 25% to 50% of wound covered
|
1 Participants
|
0 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · None
|
19 Participants
|
10 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · <25% of wound bed covered
|
4 Participants
|
1 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · 25% to 50% of wound covered
|
1 Participants
|
1 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · >50% to <75% of wound covered
|
0 Participants
|
0 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · >75% to 100% of wound covered
|
1 Participants
|
1 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · None
|
18 Participants
|
8 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · <25% of wound bed covered
|
2 Participants
|
2 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · 25% to 50% of wound covered
|
3 Participants
|
0 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · >50% to <75% of wound covered
|
0 Participants
|
1 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · >75% to 100% of wound covered
|
0 Participants
|
0 Participants
|
|
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · None
|
18 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 6, and 12Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the appearance of skin color changes surrounding the reference wound at each time point. The tool guidance is to assess tissues within 4 cm of wound edge. Dark-skinned persons show the colors "bright red" and "dark red" as a deepening of normal ethnic skin color or a purple hue. As healing occurs in dark-skinned persons, the new skin is pink and may never darken.
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=25 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Pink or normal for ethnic group
|
22 Participants
|
12 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Bright red and/or blanches to touch
|
3 Participants
|
0 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · White or grey pallor or hypopigmented
|
0 Participants
|
0 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Dark red/ or purple and/or nonblanchable
|
0 Participants
|
1 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Black or hyperpigmented
|
0 Participants
|
0 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Pink or normal for ethnic group
|
23 Participants
|
10 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Bright red and/or blanches to touch
|
0 Participants
|
0 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · White or grey pallor or hypopigmented
|
0 Participants
|
1 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Dark red/ or purple and/or nonblanchable
|
0 Participants
|
0 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Black or hyperpigmented
|
0 Participants
|
0 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Pink or normal for ethnic group
|
23 Participants
|
10 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Bright red and/or blanches to touch
|
0 Participants
|
1 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · White or grey pallor or hypopigmented
|
0 Participants
|
0 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Dark red/ or purple and/or nonblanchable
|
0 Participants
|
0 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Black or hyperpigmented
|
0 Participants
|
0 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Pink or normal for ethnic group
|
23 Participants
|
9 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Bright red and/or blanches to touch
|
0 Participants
|
0 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · White or grey pallor or hypopigmented
|
0 Participants
|
1 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Dark red/ or purple and/or nonblanchable
|
0 Participants
|
1 Participants
|
|
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Black or hyperpigmented
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 6, and 12Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the appearance and percentage of granulation tissue in the reference wound at each time point. Granulation tissue is the growth of small blood vessels and connective tissue to fill in full-thickness wounds. Tissue is healthy when bright, beefy red, shiny, and granular with a velvety appearance. Poor vascular supply appears as pale-pink or blanched to dull, dusky red color.
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=25 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Skin intact or partial-thickness wound
|
0 Participants
|
0 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Bright, beefy red; 75-100% wound filled/ or tissue overgrowth
|
10 Participants
|
6 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Bright, beefy red; <75% & >25% wound filled
|
8 Participants
|
2 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · Pink and/or dull, dusky red and/or fills ≤25% of wound
|
7 Participants
|
4 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · No granulation tissue present
|
0 Participants
|
1 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Skin intact or partial-thickness wound
|
0 Participants
|
0 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Bright, beefy red; 75-100% wound filled/ or tissue overgrowth
|
10 Participants
|
6 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Bright, beefy red; <75% & >25% wound filled
|
8 Participants
|
2 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · Pink and/or dull, dusky red and/or fills ≤25% of wound
|
5 Participants
|
3 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · No granulation tissue present
|
0 Participants
|
0 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Skin intact or partial-thickness wound
|
2 Participants
|
0 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Bright, beefy red; 75-100% wound filled/ or tissue overgrowth
|
9 Participants
|
8 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Bright, beefy red; <75% & >25% wound filled
|
9 Participants
|
3 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · Pink and/or dull, dusky red and/or fills ≤25% of wound
|
3 Participants
|
0 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · No granulation tissue present
|
0 Participants
|
0 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Skin intact or partial-thickness wound
|
2 Participants
|
0 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Bright, beefy red; 75-100% wound filled/ or tissue overgrowth
|
11 Participants
|
8 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Bright, beefy red; <75% & >25% wound filled
|
8 Participants
|
3 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · Pink and/or dull, dusky red and/or fills ≤25% of wound
|
2 Participants
|
0 Participants
|
|
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · No granulation tissue present
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 6, and 12Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the percentage of reference wound demonstrating epithelialization at each time point. Epithelialization is the process of epidermal resurfacing and appears as pink or red skin. In partial-thickness wounds, it can occur throughout the wound bed as well as from the wound edges. In full-thickness wounds, it occurs from the edges only. Use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-shaped quadrants to help determine percent of wound involved and to measure the distance the epithelial tissue extends into the wound. The mBWAT 13 categories include: Size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, and epithelialization.
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=25 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · 100% wound covered, surface intact
|
0 Participants
|
0 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · 75% - <100% wound covered and/or epithelial tissue extends >0.5 cm into wound bed
|
6 Participants
|
4 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · 50% - <75% wound covered and/or epithelial tissue extends <0.5 cm into wound bed
|
1 Participants
|
0 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · 25% - <50% wound covered
|
5 Participants
|
1 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Baseline · <25% wound covered
|
13 Participants
|
8 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · 100% wound covered, surface intact
|
1 Participants
|
0 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · 75% - <100% wound covered and/or epithelial tissue extends >0.5 cm into wound bed
|
6 Participants
|
3 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · 50% - <75% wound covered and/or epithelial tissue extends <0.5 cm into wound bed
|
3 Participants
|
0 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · 25% - <50% wound covered
|
4 Participants
|
2 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 3 · <25% wound covered
|
10 Participants
|
6 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · 100% wound covered, surface intact
|
2 Participants
|
1 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · 75% - <100% wound covered and/or epithelial tissue extends >0.5 cm into wound bed
|
6 Participants
|
2 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · 50% - <75% wound covered and/or epithelial tissue extends <0.5 cm into wound bed
|
3 Participants
|
2 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · 25% - <50% wound covered
|
2 Participants
|
2 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 6 · <25% wound covered
|
11 Participants
|
4 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · 100% wound covered, surface intact
|
9 Participants
|
5 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · 75% - <100% wound covered and/or epithelial tissue extends >0.5 cm into wound bed
|
5 Participants
|
4 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · 50% - <75% wound covered and/or epithelial tissue extends <0.5 cm into wound bed
|
3 Participants
|
0 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · 25% - <50% wound covered
|
3 Participants
|
1 Participants
|
|
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Week 12 · <25% wound covered
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 6, and 12Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
Evaluation of the number of participants demonstrating peri-wound changes in appearance as determined visually by the Investigator; categorized as normal, erythematous, edematous, eczematous, excoriated, macerated, or indurated at each time point.
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=25 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Baseline · Normal
|
22 Participants
|
11 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Baseline · Erythematous
|
0 Participants
|
0 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Baseline · Edematous
|
0 Participants
|
1 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Baseline · Eczematous
|
1 Participants
|
1 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Baseline · Excoriated
|
0 Participants
|
0 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Baseline · Macerated
|
1 Participants
|
0 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Baseline · Indurated
|
1 Participants
|
0 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 3 · Normal
|
20 Participants
|
9 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 3 · Erythematous
|
0 Participants
|
0 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 3 · Edematous
|
0 Participants
|
1 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 3 · Eczematous
|
1 Participants
|
1 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 3 · Excoriated
|
0 Participants
|
0 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 3 · Macerated
|
1 Participants
|
0 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 3 · Indurated
|
1 Participants
|
0 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 6 · Normal
|
20 Participants
|
8 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 6 · Erythematous
|
0 Participants
|
0 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 6 · Edematous
|
0 Participants
|
1 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 6 · Eczematous
|
0 Participants
|
1 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 6 · Excoriated
|
0 Participants
|
0 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 6 · Macerated
|
2 Participants
|
1 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 6 · Indurated
|
1 Participants
|
0 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 12 · Normal
|
21 Participants
|
8 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 12 · Erythematous
|
0 Participants
|
0 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 12 · Edematous
|
0 Participants
|
1 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 12 · Eczematous
|
0 Participants
|
1 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 12 · Excoriated
|
0 Participants
|
0 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 12 · Macerated
|
1 Participants
|
1 Participants
|
|
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Week 12 · Indurated
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 6 and 12Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
The change from Baseline of the wound area was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound area measurements.
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=25 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Ulcer Progression Assessed by Change From Baseline in Wound Area
Baseline, wound area
|
8.9 cm^2
Standard Deviation 11.9
|
8.7 cm^2
Standard Deviation 8.9
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Area
Week 3, wound area
|
9.9 cm^2
Standard Deviation 13.3
|
4.9 cm^2
Standard Deviation 6.4
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Area
Week 3, change in wound area
|
-0.6 cm^2
Standard Deviation 10.6
|
2.2 cm^2
Standard Deviation 4.6
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Area
Week 6, wound area
|
9.7 cm^2
Standard Deviation 16.1
|
3.7 cm^2
Standard Deviation 6.5
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Area
Week 6, change in wound area
|
-0.5 cm^2
Standard Deviation 12.2
|
3.3 cm^2
Standard Deviation 5.0
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Area
Week 12, wound area
|
7.9 cm^2
Standard Deviation 15.8
|
6.7 cm^2
Standard Deviation 18.5
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Area
Week 12, change in wound area
|
1.4 cm^2
Standard Deviation 13.7
|
0.0 cm^2
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 6, and 12Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
The change from Baseline of the wound volume was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound volume measurements.
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=25 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Ulcer Progression Assessed by Change From Baseline in Wound Volume
Baseline, wound volume
|
2.7 cm^3
Standard Deviation 5.2
|
2.1 cm^3
Standard Deviation 2.6
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Volume
Week 3, wound volume
|
2.5 cm^3
Standard Deviation 5.7
|
1.0 cm^3
Standard Deviation 1.9
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Volume
Week 3, change in wound volume
|
0.3 cm^3
Standard Deviation 1.6
|
1.0 cm^3
Standard Deviation 1.7
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Volume
Week 6, wound volume
|
2.9 cm^3
Standard Deviation 7.3
|
0.9 cm^3
Standard Deviation 2.6
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Volume
Week 6, change in wound volume
|
-0.1 cm^3
Standard Deviation 3.1
|
1.1 cm^3
Standard Deviation 2.3
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Volume
Week 12, wound volume
|
2.2 cm^3
Standard Deviation 5.6
|
2.8 cm^3
Standard Deviation 9.3
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Volume
Week 12, change in wound volume
|
0.6 cm^3
Standard Deviation 1.9
|
-0.8 cm^3
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 6, and 12Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
The change from Baseline in the wound depth was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound depth measurements.
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=25 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Ulcer Progression Assessed by Change From Baseline in Wound Depth
Baseline, wound depth
|
2.8 mm
Standard Deviation 3.6
|
3.8 mm
Standard Deviation 5.0
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Depth
Week 3, wound depth
|
1.8 mm
Standard Deviation 1.8
|
2.7 mm
Standard Deviation 4.3
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Depth
Week 3, change in wound depth
|
1.0 mm
Standard Deviation 2.9
|
1.2 mm
Standard Deviation 2.0
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Depth
Week 6, wound depth
|
1.9 mm
Standard Deviation 2.3
|
1.5 mm
Standard Deviation 2.0
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Depth
Week 6, change in wound depth
|
0.9 mm
Standard Deviation 3.3
|
2.4 mm
Standard Deviation 5.1
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Depth
Week 12, wound depth
|
1.3 mm
Standard Deviation 1.9
|
0.9 mm
Standard Deviation 1.6
|
|
Ulcer Progression Assessed by Change From Baseline in Wound Depth
Week 12, change in wound depth
|
1.6 mm
Standard Deviation 3.7
|
3.1 mm
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Weeks 3, 6 and 12Population: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
Assessment of the wound healed status (100% re-epithelialized, no drainage, no need for dressing) was analyzed at each visit to determine the healing status of the ulcer. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data.
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=24 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Number of Participants With Reference Wound Healed
Week 3, reference ulcer healed · No
|
23 Participants
|
11 Participants
|
|
Number of Participants With Reference Wound Healed
Week 3, reference ulcer healed · Yes
|
1 Participants
|
0 Participants
|
|
Number of Participants With Reference Wound Healed
Week 6, reference ulcer healed · No
|
22 Participants
|
10 Participants
|
|
Number of Participants With Reference Wound Healed
Week 6, reference ulcer healed · Yes
|
2 Participants
|
1 Participants
|
|
Number of Participants With Reference Wound Healed
Week 12, reference ulcer healed · No
|
15 Participants
|
8 Participants
|
|
Number of Participants With Reference Wound Healed
Week 12, reference ulcer healed · Yes
|
9 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline through 12 weeksPopulation: Two subjects in the standard care group withdrew prior to receiving treatment.
Analysis of the healthcare resources used related to the reference ulcer included: Number of primary and secondary dressings including use of compression therapy.
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=25 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Healthcare Resource Use Related to the Reference Ulcer Over 12 Weeks - Number of Dressings Used
|
10.4 dressings used/participant
Standard Deviation 4.8
|
18.3 dressings used/participant
Standard Deviation 20.5
|
SECONDARY outcome
Timeframe: Baseline through 12 weeksPopulation: Not all subjects attended each scheduled visit and 2 subjects from the standard care group were withdrawn prior to receiving any treatment.
Analysis of the healthcare resources used related to the reference ulcer included: Type of primary and secondary dressings including compression therapy used during each dressing change over the 12-week treatment period based on the size of the ulcer.
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=260 Dressings used per change
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=126 Dressings used per change
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change
ALLEVYN Life Non-bordered (ALNB), 10.5 x 10.5 cm
|
1.0 Dressings used per change
Standard Deviation 0.0
|
—
|
|
Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change
ALNB, 16 x 16 cm
|
1.0 Dressings used per change
Standard Deviation 0.0
|
—
|
|
Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change
ALNB, 10 x 20 cm
|
1.0 Dressings used per change
Standard Deviation 0.1
|
—
|
|
Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change
Standard care
|
—
|
1.9 Dressings used per change
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline through 12 weeksPopulation: Two subjects from the standard care group withdrew prior to receiving treatment.
Not all enrolled participants required the use of compression dressings. Of those participants who did require a compression dressing, an analysis of the healthcare resources used included the number and type of primary and secondary dressings used in relation to the reference ulcer.
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=68 Wounds
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=33 Wounds
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Healthcare Resource Use - Number and Type of Compression Dressings Used
Multi layer elastic - Profore
|
16 Wounds
|
7 Wounds
|
|
Healthcare Resource Use - Number and Type of Compression Dressings Used
Multi layer elastic other than Profore
|
15 Wounds
|
8 Wounds
|
|
Healthcare Resource Use - Number and Type of Compression Dressings Used
Multi layer inelastic
|
0 Wounds
|
0 Wounds
|
|
Healthcare Resource Use - Number and Type of Compression Dressings Used
Single layer elastic
|
2 Wounds
|
2 Wounds
|
|
Healthcare Resource Use - Number and Type of Compression Dressings Used
Single layer inelastic
|
0 Wounds
|
0 Wounds
|
|
Healthcare Resource Use - Number and Type of Compression Dressings Used
Support hosiery
|
0 Wounds
|
1 Wounds
|
|
Healthcare Resource Use - Number and Type of Compression Dressings Used
Other
|
0 Wounds
|
0 Wounds
|
|
Healthcare Resource Use - Number and Type of Compression Dressings Used
Compression dressing application not required
|
35 Wounds
|
15 Wounds
|
SECONDARY outcome
Timeframe: Baseline through 12 weeksPopulation: Two subjects from the standard care group withdrew prior to receiving treatment.
Analysis of the healthcare resources used for participants who required a hospital admission related to the reference ulcer.
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=25 Participants
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=13 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Healthcare Resource Use - Number of Participants Requiring Hospital Admission
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline through 12 weeksPopulation: Two subjects from the standard care group withdrew prior to receiving treatment.
Analysis of the healthcare resources used related to the reference ulcer included: Time in hospital (number of days spent as an inpatient due to reference ulcer).
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=1 Participants
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Healthcare Resource Use - Number of Days Participants Required In-Hospital Care
|
—
|
7 Days
|
SECONDARY outcome
Timeframe: Baseline through 12 weeksPopulation: Two subjects from the standard care group withdrew prior to receiving treatment.
Analysis of the healthcare resources used related to the reference ulcer included: Interventions/procedures related to the reference ulcer (number and type) including debridement of the ulcer.
Outcome measures
| Measure |
ALLEVYN Life Non-Bordered
n=264 Dressing changes
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=126 Dressing changes
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement
Wound debridement not required as part of care
|
159 Dressing changes
|
89 Dressing changes
|
|
Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement
Curette debridement
|
33 Dressing changes
|
11 Dressing changes
|
|
Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement
Scissors debridement
|
0 Dressing changes
|
0 Dressing changes
|
|
Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement
Scalpel debridement
|
69 Dressing changes
|
26 Dressing changes
|
|
Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement
Forceps debridement
|
1 Dressing changes
|
0 Dressing changes
|
|
Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement
Other type of debridement
|
2 Dressing changes
|
0 Dressing changes
|
Adverse Events
ALLEVYN Life Non-Bordered
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Standard Care
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ALLEVYN Life Non-Bordered
n=25 participants at risk
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=15 participants at risk
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/25 • Baseline through 12 weeks of treatment/End of Study Visit.
|
6.7%
1/15 • Number of events 1 • Baseline through 12 weeks of treatment/End of Study Visit.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/25 • Baseline through 12 weeks of treatment/End of Study Visit.
|
6.7%
1/15 • Number of events 1 • Baseline through 12 weeks of treatment/End of Study Visit.
|
|
Infections and infestations
Osteomyelitis
|
4.0%
1/25 • Number of events 1 • Baseline through 12 weeks of treatment/End of Study Visit.
|
0.00%
0/15 • Baseline through 12 weeks of treatment/End of Study Visit.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/25 • Baseline through 12 weeks of treatment/End of Study Visit.
|
6.7%
1/15 • Number of events 1 • Baseline through 12 weeks of treatment/End of Study Visit.
|
Other adverse events
| Measure |
ALLEVYN Life Non-Bordered
n=25 participants at risk
Foam Dressing
ALLEVYN Life Non-Bordered: Foam Dressing
|
Standard Care
n=15 participants at risk
Standard care dressing
Standard Care: Foam Dressing
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Number of events 1 • Baseline through 12 weeks of treatment/End of Study Visit.
|
0.00%
0/15 • Baseline through 12 weeks of treatment/End of Study Visit.
|
|
Infections and infestations
Pneumonia
|
4.0%
1/25 • Number of events 1 • Baseline through 12 weeks of treatment/End of Study Visit.
|
6.7%
1/15 • Number of events 1 • Baseline through 12 weeks of treatment/End of Study Visit.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/25 • Baseline through 12 weeks of treatment/End of Study Visit.
|
6.7%
1/15 • Number of events 1 • Baseline through 12 weeks of treatment/End of Study Visit.
|
|
Infections and infestations
Wound infection
|
4.0%
1/25 • Number of events 1 • Baseline through 12 weeks of treatment/End of Study Visit.
|
0.00%
0/15 • Baseline through 12 weeks of treatment/End of Study Visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60