Overview

This trial is active, not recruiting.

Conditions venous insufficiency, leg ulcer
Treatment bilayered cellular matrix (orcel)
Sponsor Ortec International
Start date September 2005
Trial size 60 participants
Trial identifier NCT00270972, 100-VLU-02-CLN

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Investigator Assessment of wound healing
time frame:

Secondary Outcomes

Measure
Planimetric assessment of wound healing
time frame:
Photographic assessment of wound healing
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title A Confirmatory Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (ORCEL) for the Treatment of Venous Ulcers
Trial information was received from ClinicalTrials.gov and was last updated in June 2006.
Information provided to ClinicalTrials.gov by Ortec International.