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

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

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.

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.

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