A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Venous Leg Ulcers

Study Overview
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Brief Summary
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To assess the efficacy of the PRP Concepts Fibrin Bio-Matrix and compare its performance with usual and customary practice for the treatment of chronic non-healing venous leg ulcers (VLU).

Detailed Description
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This is a prospective, randomized, single-blind, controlled, multi-center study for subjects undergoing VLU treatment. Qualified subjects will be randomized (1:1); test group (PRP Concepts Fibrin Bio-Matrix) and control group (usual and customary practice). The study will consist of 3 periods: a screening period, an active treatment period, and a follow-up period (if healed). Approximately 250 subjects will be enrolled. Subjects will be ≥18 years of age with a VLU (greater than 4 weeks duration). Each subject will be enrolled in the active treatment period for up to 12 weeks, or to closure of wound with a confirmatory visit 2 weeks after wound closure, whether such closure occurs at 12 weeks or earlier.

Official Title
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A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Venous Leg Ulcers

Conditions
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Venous Leg Ulcers

Intervention / Treatment
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* Device: PRP Concepts Fibrin Bio-Matrix
* Other: Usual and Customary Practice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medicare/Medicaid eligible Proven venous disease The index ulcer is greater than 4 weeks duration. Three or fewer ulcers that are separated by > 3.0 cm distance The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located between and including the knee and the ankle Post-debridement, the ulcer size must be between 2 cm2 and 200 cm2 Demonstrated adequate compression regimen Able and willing to attend scheduled follow-up visits and study related exams Able and willing to provide a voluntary written informed consent. Exclusion Criteria: Ulcer not of VLU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology) Greater than 30% reduction in wound size during the first two weeks of observation and treatment by the investigator Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis. Known allergy tor sensitivity to Eclipse PRP kit components (calcium chloride, calcium gluconate or acid citrate dextrose solution A (ACDA)) Serum albumin of less than 2.5 g/dL, Plasma Platelet count of less than 100 x 109/L, or Hemoglobin of less than 10.5 g/dL, Known renal failure as determined by a Creatinine > 2.5 mg/dl Malignancy at or near the ulcer site Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV Severe liver disease. Presence of additional abnormal lab values obtained within 7 days prior to the Day 0 visit determined to be clinically significant by the investigator including: WBC >13,000/cm3 or < 5, 000 cm3, or electrolytes that are outside the host institution's range of normal Radiation therapy, chemotherapy, immunosuppressive therapy or chronic steroid use within 30 days of enrollment Received another investigational device or drug within 30 days of enrollment Received allograft, autograft or xenograft within 30 days of enrollment Subject has inadequate venous access for repeated blood draw required for Eclipse RPR administrations Subject requires or is anticipated to require interventions directed at improvement of arterial perfusion to affected area Ulcer expected to be treated with any advanced therapeutics (e.g., HBOT) Presence of another wound that is concurrently treated and might interfere with treatment of index wound Subjects who are cognitively impaired and do not have a healthcare proxy Life expectancy of < 6 months.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP Concepts Fibrin Bio-Matrix<br>PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice | Device: PRP Concepts Fibrin Bio-Matrix<br>* PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice<br>Other: Usual and Customary Practice<br>* Usual and Customary Practice for non-healing venous leg ulcers<br>* Other names: Standard of Care;|
| Other: Usual and Customary Practice<br>usual and customary practice | Other: Usual and Customary Practice<br>* Usual and Customary Practice for non-healing venous leg ulcers<br>* Other names: Standard of Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete wound closure | Complete wound closure is defined as full epithelialization of the wound with the absence of drainage, durability confirmed at 2 weeks | 12 weeks | 
| Percent of wounds healed | Percent of wounds healed at 12 weeks | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Trajectory | Mean and median of percent (%) wound size changes at 4 weeks, 8 weeks and 12 weeks | 12 weeks | 
| Ulcer recurrence | Ulcer recurrence out to 3 months for subjects whose wounds heal by conclusion of 12 weeks visit. | 3 months | 
| Quality of Life Health Survey | Changes in Quality of Life scores and ability to return to previous function/resumption of normal activities | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-healing wounds, venous stasis, ulcer, platelet rich plasma