Trial Outcomes & Findings for Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds (NCT NCT00971048)
NCT ID: NCT00971048
Last Updated: 2014-01-27
Results Overview
Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, periwound color and edema, granulation tissue, and epithelialization) were each graded on a 5-point scale, with 1 being the best and 5 being the worst.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
22 - 29 days
Results posted on
2014-01-27
Participant Flow
Adults 18 years of age and older who had a DFU or PU on the foot that was a partial or full thickness wound
Participant milestones
| Measure |
HP828-101 Treating DFU
HP828-101 : Topical test article approximately the size of a nickel, applied once daily Treatment group had diabetic foot ulcers (DFU)
|
Standard of Care Treating DFU
For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel
Hydrogel for DFU (3M Tegaderm Hydrogel)
|
HP828-101 Treating PU
HP828-101 : Topical test article approximately the size of a nickel, applied once daily Treatment group had pressure ulcers (PU)
|
Standard of Care Treating PU
For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel
Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
33
|
12
|
13
|
|
Overall Study
COMPLETED
|
29
|
31
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
HP828-101 Treating DFU
HP828-101 : Topical test article approximately the size of a nickel, applied once daily Treatment group had diabetic foot ulcers (DFU)
|
Standard of Care Treating DFU
For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel
Hydrogel for DFU (3M Tegaderm Hydrogel)
|
HP828-101 Treating PU
HP828-101 : Topical test article approximately the size of a nickel, applied once daily Treatment group had pressure ulcers (PU)
|
Standard of Care Treating PU
For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel
Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
Baseline characteristics by cohort
| Measure |
HP828-101 Treating DFU
n=30 Participants
HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
|
Standard of Care Treating DFU
n=33 Participants
For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel
Hydrogel for DFU(3M Tegaderm Hydrogel)
|
HP828-101 Treating PU
n=12 Participants
HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
|
Standard of Care Treating PU
n=13 Participants
For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel
Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)
|
Total
n=88 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
61.3 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
64.1 years
STANDARD_DEVIATION 17.0 • n=4 Participants
|
62.6 years
STANDARD_DEVIATION 12.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
33 participants
n=7 Participants
|
12 participants
n=5 Participants
|
13 participants
n=4 Participants
|
88 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 22 - 29 daysPopulation: Intent-to-Treat
Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, periwound color and edema, granulation tissue, and epithelialization) were each graded on a 5-point scale, with 1 being the best and 5 being the worst.
Outcome measures
| Measure |
HP828-101 Treating DFU
n=30 Participants
HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
|
Standard of Care Treating DFU
n=33 Participants
For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel
Hydrogel for DFU(3M Tegaderm Hydrogel)
|
HP828-101 Treating PU
n=12 Participants
HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
|
Standard of Care Treating PU
n=13 Participants
For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel
Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)
|
|---|---|---|---|---|
|
Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool.
Day 22
|
20.28 units on a scale
Standard Error 0.89
|
21.38 units on a scale
Standard Error 0.85
|
20.94 units on a scale
Standard Error 1.63
|
20.59 units on a scale
Standard Error 1.57
|
|
Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool.
Day 29
|
20.12 units on a scale
Standard Error 0.98
|
18.71 units on a scale
Standard Error 0.93
|
19.78 units on a scale
Standard Error 1.67
|
17.28 units on a scale
Standard Error 1.61
|
SECONDARY outcome
Timeframe: 22 daysOutcome measures
| Measure |
HP828-101 Treating DFU
n=30 Participants
HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
|
Standard of Care Treating DFU
n=33 Participants
For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel
Hydrogel for DFU(3M Tegaderm Hydrogel)
|
HP828-101 Treating PU
n=12 Participants
HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
|
Standard of Care Treating PU
n=13 Participants
For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel
Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)
|
|---|---|---|---|---|
|
Number of Participants With Wound Closure by Day 22.
|
5 Subjects
|
1 Subjects
|
1 Subjects
|
3 Subjects
|
SECONDARY outcome
Timeframe: At every visit: Day 8, Day 15, Day 22, Day 29Population: Intent-to-Treat
100-mm VAS scale was used to evaluate pain, with 1 being healthy tissue (no pain) up to 100 (wound degeneration and severe pain)
Outcome measures
| Measure |
HP828-101 Treating DFU
n=30 Participants
HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
|
Standard of Care Treating DFU
n=33 Participants
For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel
Hydrogel for DFU(3M Tegaderm Hydrogel)
|
HP828-101 Treating PU
n=12 Participants
HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
|
Standard of Care Treating PU
n=13 Participants
For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel
Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)
|
|---|---|---|---|---|
|
Pain Assessed by a 100-mm VAS Scale.
Day 8
|
8.92 VAS Pain Scores
Standard Error 1.84
|
4.85 VAS Pain Scores
Standard Error 1.75
|
4.76 VAS Pain Scores
Standard Error 1.21
|
6.99 VAS Pain Scores
Standard Error 1.16
|
|
Pain Assessed by a 100-mm VAS Scale.
Day 15
|
8.09 VAS Pain Scores
Standard Error 2.18
|
3.21 VAS Pain Scores
Standard Error 2.07
|
3.49 VAS Pain Scores
Standard Error 2.95
|
8.85 VAS Pain Scores
Standard Error 2.83
|
|
Pain Assessed by a 100-mm VAS Scale.
Day 22
|
9.57 VAS Pain Scores
Standard Error 2.90
|
3.6 VAS Pain Scores
Standard Error 2.76
|
3.66 VAS Pain Scores
Standard Error 3.50
|
6.63 VAS Pain Scores
Standard Error 3.36
|
|
Pain Assessed by a 100-mm VAS Scale.
Day 29
|
7.16 VAS Pain Scores
Standard Error 2.41
|
1.53 VAS Pain Scores
Standard Error 2.30
|
4.33 VAS Pain Scores
Standard Error 2.36
|
8.70 VAS Pain Scores
Standard Error 2.26
|
SECONDARY outcome
Timeframe: At every visit: Day 8, Day 15, Day 22, Day 29Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound exudate type and amount) were each graded on a 5-point scale, with 1 being the best and 5 being the worst.
Outcome measures
| Measure |
HP828-101 Treating DFU
n=30 Participants
HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
|
Standard of Care Treating DFU
n=33 Participants
For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel
Hydrogel for DFU(3M Tegaderm Hydrogel)
|
HP828-101 Treating PU
n=12 Participants
HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
|
Standard of Care Treating PU
n=13 Participants
For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel
Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)
|
|---|---|---|---|---|
|
Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT)
Day 8
|
1.94 BWAT-m Exudate Score
Standard Error 0.14
|
1.90 BWAT-m Exudate Score
Standard Error 0.14
|
1.78 BWAT-m Exudate Score
Standard Error 0.20
|
2.43 BWAT-m Exudate Score
Standard Error 0.19
|
|
Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT)
Day 15
|
1.78 BWAT-m Exudate Score
Standard Error 0.14
|
1.88 BWAT-m Exudate Score
Standard Error 0.13
|
1.80 BWAT-m Exudate Score
Standard Error 0.25
|
1.95 BWAT-m Exudate Score
Standard Error 0.24
|
|
Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT)
Day 22
|
1.76 BWAT-m Exudate Score
Standard Error 0.17
|
1.77 BWAT-m Exudate Score
Standard Error 0.16
|
1.89 BWAT-m Exudate Score
Standard Error 0.32
|
2.24 BWAT-m Exudate Score
Standard Error 0.34
|
|
Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT)
Day 29
|
1.69 BWAT-m Exudate Score
Standard Error 0.14
|
1.51 BWAT-m Exudate Score
Standard Error 0.12
|
1.98 BWAT-m Exudate Score
Standard Error 0.37
|
2.02 BWAT-m Exudate Score
Standard Error 0.41
|
Adverse Events
HP828-101 Treating DFU
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care Treating DFU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HP828-101 Treating PU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care Treating PU
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HP828-101 Treating DFU
n=30 participants at risk
HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
|
Standard of Care Treating DFU
n=33 participants at risk
For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel
Hydrogel for DFU(3M Tegaderm Hydrogel)
|
HP828-101 Treating PU
n=12 participants at risk
HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
|
Standard of Care Treating PU
n=13 participants at risk
For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel
Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)
|
|---|---|---|---|---|
|
Infections and infestations
Infection of ulcer - nontarget ulcer
|
3.3%
1/30 • Number of events 1 • 29 days
|
0.00%
0/33 • 29 days
|
0.00%
0/12 • 29 days
|
0.00%
0/13 • 29 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/30 • 29 days
|
0.00%
0/33 • 29 days
|
0.00%
0/12 • 29 days
|
7.7%
1/13 • Number of events 1 • 29 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.3%
1/30 • Number of events 1 • 29 days
|
0.00%
0/33 • 29 days
|
0.00%
0/12 • 29 days
|
0.00%
0/13 • 29 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60