Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers (DEVO)
This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 16-week treatment period is complete. Follow-up visits are conducted monthly for three months in order to assess patients for longer term safety.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial|
- Complete Healing of the Study Ulcer by Week 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Time-to-Complete Healing [ Time Frame: From Week 0 visit to date subject's completely healed ulcer is 1st recorded as healed. If subject's ulcer not healed at 16 weeks, the "time until CH" was censored at 112 days. ] [ Designated as safety issue: No ]Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.
- Complete Healing by Week 16: Ulcers <= 12 Months Duration [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||August 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.
Active Comparator: 2
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
Weekly application of Profore compression dressings, in combination with systematic surgical wound debridement.
Show 70 Study Locations
|Principal Investigator:||William Marston, MD||University of North Carolina School of Medicine, Chapel Hill, NC|
|Principal Investigator:||Keith Harding, MD||Cardiff University School of Medicine, Wales, UK|
|Principal Investigator:||David Bergqvist, MD||University of Uppsala, Sweden|