The Evaluation of OrCel for the Treatment of Venous Ulcers

Ortec International60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Venous Insufficiency Leg 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 ulcer site * Uncontrolled diabetes mellitus * Malnutrition * Previous treatment with excluded medications

Locations (10)

Baptist Medical Center South

Montgomery, Alabama, United States

Associated Foot and Ankle Specialists

Phoenix, Arizona, United States

Eden Podiatry Group

Castro Valley, California, 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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