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