The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers

Conditions
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Venous Leg Ulcers

Intervention / Treatment
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* Device: Unite Biomatrix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: compression therapy<br> | |
| Active Comparator: Biologic with compression therapy<br> | Device: Unite Biomatrix<br>* collagen based, decellularized equine pericardial dressing for skin surface wounds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing pathway markers |  | baseline, day 0, 3, wk 1, 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial Bioburder |  | baseline, day 0, 3, wk 1, 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous Leg Ulcers