The Evaluation of OrCel for the Treatment of Venous Ulcers

Status unconfirmed · Not applicable

Conditions studied: Venous Insufficiency, Leg Ulcer

In brief

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.

Key facts

Study ID: NCT00270972
Run by: Ortec International
People needed: 60
Starts: 2005-09-01
Last updated by the study team: 2006-06-05

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 ulcer site
Uncontrolled diabetes mellitus
Malnutrition
Previous treatment with excluded medications

Where it is running

Baptist Medical Center South — Montgomery, Alabama, United States
Associated Foot and Ankle Specialists — Phoenix, Arizona, United States
Eden Podiatry Group — Castro Valley, California, United States
PPH Center for Wound Care and Hyperbaric Medicine — Poway, California, United States
Wound Healing Center — Terre Haute, Indiana, United States
Southside Hospital — Bay Shore, New York, United States
St Luke's Roosevelt — New York, New York, United States
Center for Advanced Wound Care — Reading, Pennsylvania, United States
Warren General Hospital — Warren, Pennsylvania, United States
Hyperbaric and Wound Care Associates — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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