Status:
COMPLETED
Evaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers
Lead Sponsor:
Ortec International
Conditions:
Venous Leg Ulcer
Venous Stasis Ulcer
Eligibility:
All Genders
18-85 years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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
- Decrease in wound size \>35% during Screening Phase
- Infection at the ulcer site
- Uncontrolled diabetes mellitus
- Previous treatment with excluded medications
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2003
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00270946
Start Date
April 1 2002
End Date
December 1 2003
Last Update
December 29 2005
Active Locations (1)
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1
Terry Treadwell, MD
Montgomery, Alabama, United States, 33134