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Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care

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ClinicalTrials.gov Identifier: NCT01716169
Recruitment Status : Completed
First Posted : October 29, 2012
Results First Posted : May 5, 2016
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
Alfred Lane, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Epidermolysis Bullosa Dystrophica
Epidermolysis Bullosa
Interventions Device: Helicoll
Device: Standard of Care Dressings
Enrollment 10
Recruitment Details Recruitment from EB Clinic patients, organization website
Pre-assignment Details  
Arm/Group Title Helicoll - Chronic Wound
Hide Arm/Group Description

Helicoll will be applied to one chronic wound (approximately 6 months or more duration)

Helicoll: Helicoll Collagen I Wound Dressing

Period Title: Overall Study
Started 10
Standard of Care Dressings Used 7
Completed 6
Not Completed 4
Reason Not Completed
Adverse Event             1
Lost to Follow-up             1
Withdrawal by Subject             1
inconsistent dressing application             1
Arm/Group Title Helicoll - Chronic Wound
Hide Arm/Group Description

Helicoll will be applied to one chronic wound (approximately 6 months or more duration)

Helicoll: Helicoll Collagen I Wound Dressing

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
8
  80.0%
Between 18 and 65 years
2
  20.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
15.6  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
5
  50.0%
Male
5
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Percentage of Wound Surface Area Change From Baseline to Week 8
Hide Description 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.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Helicoll - Chronic Wound Standard of Care Dressing - Chronic Wound
Hide Arm/Group Description:

Helicoll will be applied to one chronic wound (approximately 6 months or more duration)

Helicoll: Helicoll Collagen I Wound Dressing

Standard of Care dressings will be applied to one chronic wound
Overall Number of Participants Analyzed 3 3
Mean (95% Confidence Interval)
Unit of Measure: percentage of wound surface area
-63
(-99.1 to -26.9)
-8.1
(-34.4 to 18.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Helicoll - Chronic Wound Standard of Care - Chronic Wound
Hide Arm/Group Description

Helicoll will be applied to one chronic wound (approximately 6 months or more duration)

Helicoll: Helicoll Collagen I Wound Dressing

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.
All-Cause Mortality
Helicoll - Chronic Wound Standard of Care - Chronic Wound
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Helicoll - Chronic Wound Standard of Care - Chronic Wound
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Helicoll - Chronic Wound Standard of Care - Chronic Wound
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/10 (10.00%)      0/7 (0.00%)    
Infections and infestations     
wound infection  1/10 (10.00%)  1 0/7 (0.00%)  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Alfred Lane
Organization: Stanford School of Medicine
Phone: 650 721 7166
Responsible Party: Alfred Lane, Stanford University
ClinicalTrials.gov Identifier: NCT01716169     History of Changes
Other Study ID Numbers: 24915
First Submitted: October 25, 2012
First Posted: October 29, 2012
Results First Submitted: May 22, 2015
Results First Posted: May 5, 2016
Last Update Posted: May 5, 2016