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Evaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers

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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00270946
Study type Interventional
Source Ortec International
Contact
Status Completed
Phase N/A
Start date April 2002
Completion date December 2003
View Details
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