Clinical Trial: Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Prospective, Multicenter, Within Subject Controlled Study to Evaluate the Effect of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullos
Brief Summary: The purpose of this study is to evaluate the use of Apligraf for the treatment of nonhealing wounds in subjects with dystrophic or junctional epidermolysis bullosa. Apligraf will be evaluated for efficacy and safety compared to a conventional nonadherent dressing. A matched-pair design will be used to evaluate Apligraf treatment versus conventional treatment in 68 study pairs.
Detailed Summary:
Sponsor: Organogenesis
Current Primary Outcome: Proportion of Wounds First Achieving 100% Epithelialization of Tissue With the Absence of Drainage (i.e. Complete Wound Closure) Through Study Week 12 [ Time Frame: Through 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time Until Complete Closure [ Time Frame: through 12 weeks ]
- Rate of Complete Wound Closure Over Time [ Time Frame: through 12 weeks ]
- Recurrence of Epidermolysis Bullosa (EB) Lesions [ Time Frame: through 12 months ]
- Reduction of Intensity of Pain [ Time Frame: through 12 weeks ]
- Proportion of Wounds Experiencing an Adverse Event [ Time Frame: through 12 months ]
Original Secondary Outcome: 1. Time until complete wound closure 2. Rate of complete wound closure over time 3. Recurrence of EB lesions 4. Reduction of intensity of pain 5. Proportion of wounds experiencing an adverse event [ Time Frame: through 12 months ]
Information By: Organogenesis
Dates:
Date Received: December 21, 2007
Date Started: December 2007
Date Completion:
Last Updated: June 25, 2010
Last Verified: June 2010
