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The Evaluation of OrCel for the Treatment of Venous Ulcers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2006 by Ortec International.
Recruitment status was:  Active, not recruiting
Information provided by:
Ortec International Identifier:
First received: December 28, 2005
Last updated: June 2, 2006
Last verified: June 2006

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
Intervention Model: Parallel Assignment
Masking: None (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:

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

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00270972

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 Identifier: NCT00270972     History of Changes
Other Study ID Numbers: 100-VLU-02-CLN
Study First Received: December 28, 2005
Last Updated: June 2, 2006

Keywords provided by Ortec International:
Venous leg ulcer
Venous insufficiency

Additional relevant MeSH terms:
Leg Ulcer
Venous Insufficiency
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Vascular Diseases
Cardiovascular Diseases
Varicose Veins processed this record on September 21, 2017