Venous Insufficiency Clinical Trial
Official title:
A Confirmatory Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (ORCEL) for the Treatment of Venous Ulcers
This study was designed to confirm the clinical benefits and safety of OrCel in the
treatment of venous ulcers. OrCel and standard care are compared to standard care alone.
Standard care consists of currently accepted compression therapy.
Patients are treated for 12 weeks. Patients with healed ulcers are followed for an
additional 12 weeks to assess durability of the healed wound.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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