Evaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers

Venous Leg Ulcer Clinical Trial

Official title:

A Pivotal Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270946
• Other study ID #: 100-VLU-01-CLN
• Status: Completed
• Phase: N/A
• First received: December 28, 2005
• Last updated: December 28, 2005
• Start date: April 2002
• Est. completion date: December 2003

Study information

• Verified date: December 2005
• 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 evaluate the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care were compared to standard care alone. Standard care consisted of currently accepted compression therapy.

Patients were treated for 12 weeks. Patients with healed ulcers were followed for an additional 12 weeks to assess durability of the healed wound.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2003
• 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 the ulcer site

• Uncontrolled diabetes mellitus

• Previous treatment with excluded medications

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer
• Venous Stasis Ulcer

Intervention

Device:
• Bilayered Cellular Matrix (OrCel)

Locations

Country	Name	City	State
United States	Terry Treadwell, MD	Montgomery	Alabama

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