Venous Leg Ulcers
Conditions
Keywords
Venous Leg Ulcers
Brief summary
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.
Interventions
DEVICEUnite Biomatrix
collagen based, decellularized equine pericardial dressing for skin surface wounds
Sponsors
Synovis Surgical Innovations
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healing pathway markers | baseline, day 0, 3, wk 1, 2 |
Secondary
| Measure | Time frame |
|---|---|
| Bacterial Bioburder | baseline, day 0, 3, wk 1, 2 |
Countries
United States
Outcome results
None listed