A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial
A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial
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.
Inclusion Criteria:
Exclusion Criteria:
Chapel Hill, North Carolina 27599, United States
Freiburg im Breisgau, D-79100, Germany
Hamburg, D-22177, Germany
Gdynia, 81-415, Poland
Nowy SÄ…cz, 33-300, Poland
Sydenham, Durban, 4091, South Africa