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The Evaluation of OrCel for the Treatment of Venous Ulcers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Ortec International.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ortec International
ClinicalTrials.gov Identifier:
NCT00270972
First received: December 28, 2005
Last updated: June 2, 2006
Last verified: June 2006
History of Changes
  Purpose

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.


Condition Intervention
Venous Insufficiency
Leg Ulcer
 Device: Bilayered Cellular Matrix (OrCel)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Confirmatory Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (ORCEL) for the Treatment of Venous Ulcers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ortec International:

Primary Outcome Measures:
  • Investigator Assessment of wound healing

Secondary Outcome Measures:
  • Planimetric assessment of wound healing
  • Photographic assessment of wound healing

Estimated Enrollment: 60
Study Start Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270972

Locations
United States, Alabama
Baptist Medical Center South
Montgomery, Alabama, United States, 36116
United States, Arizona
Associated Foot and Ankle Specialists
Phoenix, Arizona, United States, 85015
United States, California
Eden Podiatry Group
Castro Valley, California, United States, 94546
PPH Center for Wound Care and Hyperbaric Medicine
Poway, California, United States, 92064
United States, Indiana
Wound Healing Center
Terre Haute, Indiana, United States, 47807
United States, New York
Southside Hospital
Bay Shore, New York, United States, 11706
St Luke's Roosevelt
New York, New York, United States, 10025
United States, Pennsylvania
Center for Advanced Wound Care
Reading, Pennsylvania, United States, 19601
Warren General Hospital
Warren, Pennsylvania, United States, 16365
United States, Wisconsin
Hyperbaric and Wound Care Associates
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Ortec International
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00270972     History of Changes
Other Study ID Numbers: 100-VLU-02-CLN
Study First Received: December 28, 2005
Last Updated: June 2, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Ortec International:
Venous leg ulcer
Venous insufficiency
OrCel

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Varicose Ulcer
Venous Insufficiency
Skin Ulcer
 Skin Diseases
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013