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

Ortec International130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Venous Leg Ulcer Venous Stasis Ulcer

Interventions

Bilayered Cellular Matrix (OrCel)DEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Terry Treadwell, MD

Montgomery, Alabama, United States

Outcomes

Primary Outcomes

Investigator assessment of wound healing

Secondary Outcomes

Planimetric assessment of wound healing

Photographic assessment of wound healing

Data from ClinicalTrials.gov

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