The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers

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