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

Not Applicable

Completed

• Conditions: Venous Leg Ulcer; Venous Stasis Ulcer

• Registration Number: NCT00270946
• Lead Sponsor: Ortec International

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study Completion: 2003-12
• Status Verified: 2005-12
• Study First Submitted: 2005-12-28
• Study First Submitted QC: 2005-12-28
• Last Update Submitted: 2005-12-28
• Study First Posted: 2005-12-29
• Last Update Posted: 2005-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Investigator assessment of wound healing

Secondary Outcome Measures

Name	Time	Method
Planimetric assessment of wound healing
Photographic assessment of wound healing

Trial Locations

Locations (1)

Terry Treadwell, MD; 🇺🇸 Montgomery, Alabama, United States