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

Completed · Not applicable

Conditions studied: Venous Leg Ulcer, Venous Stasis Ulcer

In brief

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.

Key facts

Study ID

NCT00270946

Run by

Ortec International

People needed

130

Starts

2002-04-01

Expected to finish

2003-12-01

Last updated by the study team

2005-12-29

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any race, between 18 and 85 years of age
• Male or female
• Chronic venous insufficiency
• Ulcer size between 2 and 20 sq cm, inclusive
• Ulcer present for at least one month
• ABI >0.7

You may not qualify if…

• Decrease in wound size >35% during Screening Phase
• Infection at the ulcer site
• Uncontrolled diabetes mellitus
• Previous treatment with excluded medications

Where it is running

• Terry Treadwell, MD — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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