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NCT00270972 Clinical Trial

The Evaluation of OrCel for the Treatment of Venous Ulcers

Venous Insufficiency Clinical Trial

Official title:
A Confirmatory Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (ORCEL) for the Treatment of Venous Ulcers

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00270972
Other study ID # 100-VLU-02-CLN
Secondary ID
Status Active, not recruiting
Phase N/A
First received December 28, 2005
Last updated June 2, 2006
Start date September 2005

Study information
Verified date June 2006
Source Ortec International
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Bilayered Cellular Matrix (OrCel)

Locations
Country Name City State
United States Southside Hospital Bay Shore New York
United States Eden Podiatry Group Castro Valley California
United States Hyperbaric and Wound Care Associates Milwaukee Wisconsin
United States Baptist Medical Center South Montgomery Alabama
United States St Luke's Roosevelt New York New York
United States Associated Foot and Ankle Specialists Phoenix Arizona
United States PPH Center for Wound Care and Hyperbaric Medicine Poway California
United States Center for Advanced Wound Care Reading Pennsylvania
United States Wound Healing Center Terre Haute Indiana
United States Warren General Hospital Warren Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Ortec International

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Investigator Assessment of wound healing
Secondary Planimetric assessment of wound healing
Secondary Photographic assessment of wound healing
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