NCT00270946

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

A Pivotal Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (planned)
• Sponsor: Ortec International · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Leg Ulcer
• Venous Stasis Ulcer

Interventions

Type	Name	Description
DEVICE	Bilayered Cellular Matrix (OrCel)

Timeline

• Start date: 2002-04-01
• Completion: 2003-12-01
• First posted: 2005-12-29
• Last updated: 2005-12-29

Locations

1 site across 1 country: United States