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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: The purpose of this study is to test the effectiveness of Helicoll (a collagen wound dressing) in treating chronic and non-chronic wounds of recessive dystrophic epidermolysis bullosa (RDEB) patients. Helicoll will be compared to standard wound dressings.

Detailed Summary:
Sponsor: Stanford University

Current Primary Outcome: Percentage of Wound Surface Area Change From Baseline to Week 8 [ Time Frame: Baseline and Week 8 ]

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.


Original Primary Outcome: Proportion of wounds achieving 100% re-epithelialization at Week 8 [ Time Frame: Week 8 ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Stanford University

Dates:
Date Received: October 25, 2012
Date Started: October 2012
Date Completion:
Last Updated: April 1, 2016
Last Verified: April 2016