The Evaluation of OrCel for the Treatment of Venous Ulcers
This trial is active, not recruiting.
|Conditions||venous insufficiency, leg ulcer|
|Treatment||bilayered cellular matrix (orcel)|
|Start date||September 2005|
|Trial size||60 participants|
|Trial identifier||NCT00270972, 100-VLU-02-CLN|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Montgomery, AL||Baptist Medical Center South||no longer recruiting|
|Phoenix, AZ||Associated Foot and Ankle Specialists||no longer recruiting|
|Castro Valley, CA||Eden Podiatry Group||no longer recruiting|
|Poway, CA||PPH Center for Wound Care and Hyperbaric Medicine||no longer recruiting|
|Terre Haute, IN||Wound Healing Center||no longer recruiting|
|Bay Shore, NY||Southside Hospital||no longer recruiting|
|New York, NY||St Luke's Roosevelt||no longer recruiting|
|Reading, PA||Center for Advanced Wound Care||no longer recruiting|
|Warren, PA||Warren General Hospital||no longer recruiting|
|Milwaukee, WI||Hyperbaric and Wound Care Associates||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Investigator Assessment of wound healing
Planimetric assessment of wound healing
Photographic assessment of wound healing
Male or female participants from 18 years up to 85 years old.
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
|Official title||A Confirmatory Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (ORCEL) for the Treatment of Venous Ulcers|
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