Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers (DEVO)
|ClinicalTrials.gov Identifier: NCT00909870|
Recruitment Status : Completed
First Posted : May 29, 2009
Results First Posted : February 4, 2013
Last Update Posted : August 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Venous Leg Ulcer||Device: Dermagraft(R) Device: Profore||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||537 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial|
|Study Start Date :||June 2009|
|Primary Completion Date :||May 2011|
|Study Completion Date :||August 2011|
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.
- Complete Healing of the Study Ulcer by Week 16. [ Time Frame: 16 weeks ]
- 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. ]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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909870
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|