A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Pressure Ulcers
A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Pressure Ulcers
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 pressure ulcers (PU).
This is a prospective, randomized, single-blind, controlled, multi-center study for subjects
 undergoing PU 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 PU (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.
Inclusion Criteria:

 Medicare/Medicaid eligible Ulcer of pressure/shear etiology 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 on the heel, ischium, sacrum, and trochanter Post-debridement, the
 ulcer size must be between 2 cm2 and 200 cm2 Demonstrated adequate offloading 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:

 Stage I pressure ulcers Ulcers that are unstageable or of deep tissue morphology that have
 yet to become an open wound Ulcer not of PU pathophysiology (e.g., pure diabetic,
 vasculitic, radiation, rheumatoid, collagen vascular disease, venous, 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, 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.