Status:
UNKNOWN
The Evaluation of OrCel for the Treatment of Venous Ulcers
Lead Sponsor:
Ortec International
Conditions:
Venous Insufficiency
Leg Ulcer
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 c...
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 ulcer site
- Uncontrolled diabetes mellitus
- Malnutrition
- Previous treatment with excluded medications
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00270972
Start Date
September 1 2005
Last Update
June 5 2006
Active Locations (10)
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1
Baptist Medical Center South
Montgomery, Alabama, United States, 36116
2
Associated Foot and Ankle Specialists
Phoenix, Arizona, United States, 85015
3
Eden Podiatry Group
Castro Valley, California, United States, 94546
4
PPH Center for Wound Care and Hyperbaric Medicine
Poway, California, United States, 92064