NCT00909870

Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers

A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 537 (actual)
• Sponsor: Organogenesis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	Dermagraft(R)	Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.
DEVICE	Profore	Weekly application of Profore compression dressings, in combination with systematic surgical wound debridement.

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-05-01
• Completion: 2011-08-01
• First posted: 2009-05-29
• Last updated: 2018-06-18
• Results posted: 2013-02-04

Locations

70 sites across 8 countries: United States, Austria, Estonia, Germany, Poland, South Africa, Sweden, United Kingdom