A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Non-Healing Diabetic Foot Ulcers

Study Overview
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Brief Summary
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A prospective, randomized, controlled, clinical study to establish clinical based evidence of PRP Concepts Fibrin Bio-Matrix and compare its performance with the usual and customary practice for the treatment of Wagner 1 or 2 DFUs.

Detailed Description
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This is a prospective, randomized, single-blind, controlled, multi-center study for subjects undergoing DFU 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 chronic Wagner grade 1 or 2 DFU (greater than 1 month 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 Non-Healing Diabetic Foot Ulcers

Conditions
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Diabetic Foot 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 eligible A full thickness diabetic foot ulcer with a viable wound bed Diabetes mellitus (type I or II) that is adequately controlled The ulcer is greater than 4 weeks duration. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (index ulcer) is a Wagner 1 or 2 DFU (see Appendix for Wagner Classification) that is located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces but not on the heel). Post-debridement, the ulcer size must be between 0.5 - 20 cm2. One of the following assessments was completed to confirm pedal circulation: ankle / brachial index is between 0.7 to 1.2; transcutaneous partial pressure oxygen (TcPO2) > 30 mmHg at the ankle; or toe pressure of >40mm Hg or a doppler waveform consistent with adequate flow in the foot (biphasic or triphasic) Able and willing to provide a voluntary written informed consent. Able and willing to wear an off-loading device or orthopedic shoe Able and willing to attend scheduled follow-up visits and study related exams Exclusion Criteria: Greater than 30% reduction in wound size during the first two weeks of observation and treatment by the investigator Wagner 3, 4, 5 DFU Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis Wounds that are likely to require dressing changes more frequent than twice weekly (heavy exudates). Known allergy tor sensitivity to Eclipse PRP kit components (calcium chloride, calcium gluconate or acid citrate dextrose solution A (ACDA)) Presence of Gangrene Active Charcot's disease as determined by clinical and radiographic examination of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers) Malignancy at or near the ulcer site Known serum albumin < 2.5 mg/dl, Known renal failure as determined by a Creatinine > 2.5 mg/dl, Plasma Platelet count of less than 100 x 109/L, Hemoglobin of less than 10.5 g/dL Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV Severe liver disease. Severe liver disease is defined as known history of chronic hepatitis or cirrhosis &/or the following abnormal Liver Function Tests: ALT & AST >35, ALP >120, PT >12 seconds. 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, chronic steroid use or immunosuppressive therapy 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) Any condition judged by the investigator that would cause the study to be detrimental to the subject Alcohol or drug abuse, defined as current medical treatment for substance abuse 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP Concepts Fibrin Bio-Matrix<br>PRP Concepts Fibrin Bio-Matrix | Device: PRP Concepts Fibrin Bio-Matrix<br>* Application of PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice<br>Other: Usual and Customary Practice<br>* Usual and customary care for non-healing wounds<br>* Other names: Standard of Care;|
| Active Comparator: Usual and customary practice<br>Usual and customary practice | Other: Usual and Customary Practice<br>* Usual and customary care for non-healing wounds<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 | Percentage of closure of the wound | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Trajectory | Mean of percent (%) wound size changes at 4 weeks, 8 weeks and 12 weeks | 4, 8, 12 weeks | 
| Ulcer Recurrence | Ulcer recurrence out to 3 months for subjects whose wounds heal by conclusion of 12 week visit. | 3 months | 
| Quality of Life score | 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 wound, diabetic foot ulcer, platelet rich plasma