The Evaluation of OrCel for the Treatment of Venous Ulcers
- Conditions
- Leg UlcerVenous Insufficiency
- Registration Number
- NCT00270972
- Lead Sponsor
- Ortec International
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- Decrease in wound size >35% during Screening Phase
- Infection at ulcer site
- Uncontrolled diabetes mellitus
- Malnutrition
- 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 (10)
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
Baptist Medical Center South🇺🇸Montgomery, Alabama, United States