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

ORTEC

Status: Completed

Conditions: Venous Leg Ulcer; Venous Stasis Ulcer

Treatments: Device: Bilayered Cellular Matrix (OrCel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00270946

100-VLU-01-CLN

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)