- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00270972
The Evaluation of OrCel for the Treatment of Venous Ulcers
A Confirmatory Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (ORCEL) for the Treatment of Venous Ulcers
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Montgomery, Alabama, United States, 36116
- Baptist Medical Center South
-
-
Arizona
-
Phoenix, Arizona, United States, 85015
- Associated Foot and Ankle Specialists
-
-
California
-
Castro Valley, California, United States, 94546
- Eden Podiatry Group
-
Poway, California, United States, 92064
- PPH Center for Wound Care and Hyperbaric Medicine
-
-
Indiana
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Terre Haute, Indiana, United States, 47807
- Wound Healing Center
-
-
New York
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Bay Shore, New York, United States, 11706
- Southside Hospital
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New York, New York, United States, 10025
- St Luke's Roosevelt
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Pennsylvania
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Reading, Pennsylvania, United States, 19601
- Center for Advanced Wound Care
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Warren, Pennsylvania, United States, 16365
- Warren General Hospital
-
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Wisconsin
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Milwaukee, Wisconsin, United States, 53215
- Hyperbaric and Wound Care Associates
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 ulcer site
- Uncontrolled diabetes mellitus
- Malnutrition
- Previous treatment with excluded medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Investigator Assessment of wound healing
|
Secondary Outcome Measures
Outcome Measure |
---|
Planimetric assessment of wound healing
|
Photographic assessment of wound healing
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100-VLU-02-CLN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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