The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers

Baxter

Status: Withdrawn

Conditions: Venous Leg Ulcers

Treatments: Device: Unite Biomatrix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00953563

U0802

Details and patient eligibility

About

The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and compare its performance with the standard of care, compression therapy alone for the treatment of venous leg ulcers.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• venous ulcer confirmed w/ duplex ultrasound

• ulcer greater than 6 months duration

• post-debridement, the ulcer size must be >5cm2

• at least 18 years old

• ABI is between 0.7 to 1.2 and/or one of the following:

  • TcPO2 > 30mmHg at the ankle
  • Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)

• able and willing to provide a voluntary written informed consent

• three or fewer ulcers separated by >3.0 cm distance

• able and willing to attend scheduled follow-up visits and study related exams

Exclusion criteria

• greater than 20% reduction in wound size during the first 2 weeks of observation with the investigator
• ulcer with exposed bone or tendon
• clinical infection at the studied ulcer site including cellulitis and osteomyelitis
• ulcer of a non-venous insufficiency etiology
• phlebitis or deep leg vein thrombosis in past 30 days
• arterial bypass in previous 30 days
• severe anemia (Hgb<8)
• serum albumin <3.0
• uncompensated congestive heart failure
• renal failure with Creatinine >2.5mg/dl
• rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV
• severe liver disease as defined by treating physician
• uncontrolled diabetes mellitus determined by treating physician
• malignancy at or near the ulcer site
• any condition judged by the PI that would cause the study to be detrimental to the patient
• known allergy to equine derived tissue
• received another investigational device or drug within 30 days of Day 0
• radiation therapy at the wound site
• chemotherapy or immunosuppressive therapy within 30 days of enrollment
• received another allograft, autograft, xenograft within 30 days of the study
• pregnant or nursing women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

compression therapy

No Intervention group

Biologic with compression therapy

Active Comparator group

Treatment:

Device: Unite Biomatrix