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