Trial Outcomes & Findings for VLU Dressing Study (NCT NCT03621592)
NCT ID: NCT03621592
Last Updated: 2025-08-26
Results Overview
Mean change in bacterial load in Colony Forming Units (CFU)/grams will be assessed from tissue samples
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Baseline, Up to 8 weeks
Results posted on
2025-08-26
Participant Flow
Participant milestones
| Measure |
Cutimed® Sorbact®
Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks.
Cutimed® Sorbact®: Dialkylcarbomoyl chloride based wound dressing
|
Acticoat®
Participants in this group will receive the Acticoat intervention for 6 weeks.
Acticoat®: Silver impregnated contact layer dressing
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Cutimed® Sorbact®
Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks.
Cutimed® Sorbact®: Dialkylcarbomoyl chloride based wound dressing
|
Acticoat®
Participants in this group will receive the Acticoat intervention for 6 weeks.
Acticoat®: Silver impregnated contact layer dressing
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Lack of Improvement
|
1
|
0
|
|
Overall Study
Preference to receive wound care closer to home
|
1
|
0
|
|
Overall Study
Lack of healing
|
0
|
2
|
Baseline Characteristics
VLU Dressing Study
Baseline characteristics by cohort
| Measure |
Cutimed® Sorbact®
n=15 Participants
Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks.
Cutimed® Sorbact®: Dialkylcarbomoyl chloride based wound dressing
|
Acticoat®
n=16 Participants
Participants in this group will receive the Acticoat intervention for 6 weeks.
Acticoat®: Silver impregnated contact layer dressing
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
59.33 years
STANDARD_DEVIATION 12.81 • n=5 Participants
|
58.25 years
STANDARD_DEVIATION 10.44 • n=7 Participants
|
58.77 years
STANDARD_DEVIATION 11.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Childbearing potential
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Weight
|
90.84 kilograms
STANDARD_DEVIATION 20.73 • n=5 Participants
|
97.93 kilograms
STANDARD_DEVIATION 21.68 • n=7 Participants
|
94.12 kilograms
STANDARD_DEVIATION 20.64 • n=5 Participants
|
|
Height
|
173.44 centimeters
STANDARD_DEVIATION 11.80 • n=5 Participants
|
172.93 centimeters
STANDARD_DEVIATION 10.95 • n=7 Participants
|
173.0 centimeters
STANDARD_DEVIATION 11.19 • n=5 Participants
|
|
Tobacco use
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Length of tobacco use
|
26.5 years (mean)
STANDARD_DEVIATION 13.43 • n=5 Participants
|
24.69 years (mean)
STANDARD_DEVIATION 16.48 • n=7 Participants
|
25.29 years (mean)
STANDARD_DEVIATION 14.29 • n=5 Participants
|
|
Tobacco cessation years
|
23 years
STANDARD_DEVIATION 17.3 • n=5 Participants
|
12 years
STANDARD_DEVIATION 4.24 • n=7 Participants
|
17.5 years
STANDARD_DEVIATION 10.77 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Up to 8 weeksMean change in bacterial load in Colony Forming Units (CFU)/grams will be assessed from tissue samples
Outcome measures
| Measure |
Cutimed® Sorbact®
n=11 Participants
Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks.
Cutimed® Sorbact®: Dialkylcarbomoyl chloride based wound dressing
|
Acticoat®
n=12 Participants
Participants in this group will receive the Acticoat intervention for 6 weeks.
Acticoat®: Silver impregnated contact layer dressing
|
|---|---|---|
|
Change in Bacterial Load
|
12678.81 CFU/gram
Standard Deviation 23698.6
|
33190.8 CFU/gram
Standard Deviation 57882.61
|
SECONDARY outcome
Timeframe: Up 6 weeksWound healing rate (in cm\^2/week) will be calculated by measuring the wound area
Outcome measures
| Measure |
Cutimed® Sorbact®
n=15 Participants
Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks.
Cutimed® Sorbact®: Dialkylcarbomoyl chloride based wound dressing
|
Acticoat®
n=16 Participants
Participants in this group will receive the Acticoat intervention for 6 weeks.
Acticoat®: Silver impregnated contact layer dressing
|
|---|---|---|
|
Wound Healing Rate
|
.179 cm^2/week
Standard Deviation .272
|
.122 cm^2/week
Standard Deviation .258
|
SECONDARY outcome
Timeframe: Up to 8 weeksThe percentage of subjects achieving complete healing of ulcer at the evaluation of treating physician will be reported
Outcome measures
| Measure |
Cutimed® Sorbact®
n=15 Participants
Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks.
Cutimed® Sorbact®: Dialkylcarbomoyl chloride based wound dressing
|
Acticoat®
n=16 Participants
Participants in this group will receive the Acticoat intervention for 6 weeks.
Acticoat®: Silver impregnated contact layer dressing
|
|---|---|---|
|
Percentage of Subjects With Complete Healing
|
20 percent of patients
|
0 percent of patients
|
SECONDARY outcome
Timeframe: Up to 8 weeksThe Pain Visual Analog Scale (VAS) has range from 0 (no pain) to 100 (worst possible pain). Mean change in scores will be reported from last visit compared to baseline will be reported.
Outcome measures
| Measure |
Cutimed® Sorbact®
n=7 Participants
Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks.
Cutimed® Sorbact®: Dialkylcarbomoyl chloride based wound dressing
|
Acticoat®
n=8 Participants
Participants in this group will receive the Acticoat intervention for 6 weeks.
Acticoat®: Silver impregnated contact layer dressing
|
|---|---|---|
|
Pain as Measured by VAS Scores
|
.43 units on a scale
Standard Deviation 34.9
|
-16.9 units on a scale
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: Up to 8 weeksWQoL is a 17 item questionnaire with each question scored on a 5 point scale, where 0 is "not at all" and 5 is "very much". WQoL has a total score ranging from 0 to 85 with a lower score indicating better quality of life. Mean change in scores will be reported from last visit compared to baseline will be reported.
Outcome measures
| Measure |
Cutimed® Sorbact®
n=11 Participants
Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks.
Cutimed® Sorbact®: Dialkylcarbomoyl chloride based wound dressing
|
Acticoat®
n=14 Participants
Participants in this group will receive the Acticoat intervention for 6 weeks.
Acticoat®: Silver impregnated contact layer dressing
|
|---|---|---|
|
Wound Quality of Life (WQoL) Scores
|
-9.1 units on a scale
Standard Deviation 14.5
|
-4.1 units on a scale
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Up to 8 weeksThe Euro Quality of life-5-Dimension-5-Level (EQ-5D-5L) is averaged based off the 5 point scale, where 0 is "no problems" and 5 is "extreme problems". Difference in scores will be reported from last visit compared to baseline will be reported.
Outcome measures
| Measure |
Cutimed® Sorbact®
n=12 Participants
Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks.
Cutimed® Sorbact®: Dialkylcarbomoyl chloride based wound dressing
|
Acticoat®
n=14 Participants
Participants in this group will receive the Acticoat intervention for 6 weeks.
Acticoat®: Silver impregnated contact layer dressing
|
|---|---|---|
|
EQ-5D-5L Quality of Life Scores
|
0.12 units on a scale
Standard Deviation 0.23
|
0.08 units on a scale
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: Up to 8 weeksAs assessed by treating physician
Outcome measures
| Measure |
Cutimed® Sorbact®
n=15 Participants
Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks.
Cutimed® Sorbact®: Dialkylcarbomoyl chloride based wound dressing
|
Acticoat®
n=16 Participants
Participants in this group will receive the Acticoat intervention for 6 weeks.
Acticoat®: Silver impregnated contact layer dressing
|
|---|---|---|
|
Number of Adverse Events
|
3 number of adverse events
|
2 number of adverse events
|
Adverse Events
Cutimed® Sorbact®
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Acticoat®
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cutimed® Sorbact®
n=15 participants at risk
Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks.
Cutimed® Sorbact®: Dialkylcarbomoyl chloride based wound dressing
|
Acticoat®
n=16 participants at risk
Participants in this group will receive the Acticoat intervention for 6 weeks.
Acticoat®: Silver impregnated contact layer dressing
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Cutaneous infection
|
13.3%
2/15 • Number of events 2 • Up to 8 weeks from start date
|
12.5%
2/16 • Number of events 2 • Up to 8 weeks from start date
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignancy
|
6.7%
1/15 • Number of events 1 • Up to 8 weeks from start date
|
0.00%
0/16 • Up to 8 weeks from start date
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place