Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers (DEVO)
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|ClinicalTrials.gov Identifier: NCT00909870|
Recruitment Status : Completed
First Posted : May 29, 2009
Results First Posted : February 4, 2013
Last Update Posted : June 18, 2018
|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|
|Actual Primary Completion Date :||May 2011|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909870
|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|