The Evaluation of OrCel for the Treatment of Venous Ulcers

ORTEC

Status: Unknown

Conditions: Venous Insufficiency; Leg Ulcer

Treatments: Device: Bilayered Cellular Matrix (OrCel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00270972

100-VLU-02-CLN

Details and patient eligibility

About

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.

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 ulcer site
• Uncontrolled diabetes mellitus
• Malnutrition
• Previous treatment with excluded medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)