Trial Outcomes & Findings for Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care (NCT NCT01716169)
NCT ID: NCT01716169
Last Updated: 2016-05-05
Results Overview
Change was assessed in terms of wound surface area, as measured using the ARANZ camera. Week 8 surface area measurement was compared to baseline surface area measurement and percentage in size change was calculated.
COMPLETED
NA
10 participants
Baseline and Week 8
2016-05-05
Participant Flow
Recruitment from EB Clinic patients, organization website
Participant milestones
| Measure |
Helicoll - Chronic Wound
Helicoll will be applied to one chronic wound (approximately 6 months or more duration)
Helicoll: Helicoll Collagen I Wound Dressing
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
Standard of Care Dressings Used
|
7
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Helicoll - Chronic Wound
Helicoll will be applied to one chronic wound (approximately 6 months or more duration)
Helicoll: Helicoll Collagen I Wound Dressing
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
inconsistent dressing application
|
1
|
Baseline Characteristics
Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care
Baseline characteristics by cohort
| Measure |
Helicoll - Chronic Wound
n=10 Participants
Helicoll will be applied to one chronic wound (approximately 6 months or more duration)
Helicoll: Helicoll Collagen I Wound Dressing
|
|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
15.6 years
STANDARD_DEVIATION 5.6 • n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Change was assessed in terms of wound surface area, as measured using the ARANZ camera. Week 8 surface area measurement was compared to baseline surface area measurement and percentage in size change was calculated.
Outcome measures
| Measure |
Helicoll - Chronic Wound
n=3 Participants
Helicoll will be applied to one chronic wound (approximately 6 months or more duration)
Helicoll: Helicoll Collagen I Wound Dressing
|
Standard of Care Dressing - Chronic Wound
n=3 Participants
Standard of Care dressings will be applied to one chronic wound
|
|---|---|---|
|
Percentage of Wound Surface Area Change From Baseline to Week 8
|
-63 percentage of wound surface area
Interval -99.1 to -26.9
|
-8.1 percentage of wound surface area
Interval -34.4 to 18.1
|
Adverse Events
Helicoll - Chronic Wound
Standard of Care - Chronic Wound
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Helicoll - Chronic Wound
n=10 participants at risk
Helicoll will be applied to one chronic wound (approximately 6 months or more duration)
Helicoll: Helicoll Collagen I Wound Dressing
|
Standard of Care - Chronic Wound
n=7 participants at risk
Standard of Care wound dressings (e.g. Vaseline gauze) will be applied to one chronic wound (of approximately 6 months duration) if the subject has more than one chronic wound of approximately the same size and duration as Helicoll chronic wound.
|
|---|---|---|
|
Infections and infestations
wound infection
|
10.0%
1/10 • Number of events 1
|
0.00%
0/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place