Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers

To prospectively evaluate the safety and efficacy of an Autologous Platelet-Rich Fibrin Plasma system when applied in conjunction with Standard of Care for management of chronic lower extremity wounds.

Inclusion Criteria: 1. Female or Male, plus ≥18 years of age at the time the study Informed Consent is signed. 2. Proven and medically diagnosed chronic lower extremity ulcer. Subject's ulcer extends through the dermis and into subcutaneous tissue (granulation tissue may be present) but without exposure of muscle, tendon, bone or joint capsule. 3. For subjects with potentially multiple eligible lower extremity ulcers, the largest ulcer will be selected as the target ulcer for study. There must be at least 4 cm between the target ulcer and other ulcer(s). 4. The target wound surface area is between 1 cm2 (minimum) and 20 cm2 (maximum) post debridement by the study wound care provider. 5. The target ulcer has no visible signs of healing objectively, less than 40% reduction in wound size in the last 4-weeks. 6. Target wound has been deemed present for ≥ 1-month (4-weeks), and had a maximum of 52-weeks of SOC prior to the first study screening visit. 7. Post-debridement, subject's wound is free of necrotic debris and appears to be made up of healthy vascularized tissue. 8. The target ulcer is free of clinical signs of infection, identified by inflammation (redness, warmth, swelling, tenderness, or pain) or purulent exudates (Lipsky et al, 2012). 9. Subject has adequate perfusion to the impacted limb - as confirmed by vascular evaluation: ABI of ≥ 0.7 and ≤ 1.3, TBI ≥ 0.6, TCOM ≥ 40mmHg, PVR is biphasic. 10. Subject must be able to read, speak, understand, and sign the Informed Consent Form. 11. Female subjects must have a negative urine pregnancy test prior to the first treatment. 12. Willing and able to adhere to the study protocol, plus treatment and follow-up schedule and pre/post-treatment care instructions. 13. Willing to have photographs taken of the target wound and agree to the use of photographs for presentation, educational or marketing purposes. 14. Agree to not undergo any other procedure(s) or add any new treatment modalities in the target area during the study. Exclusion Criteria: 1. Ulcer is not medically diagnosed as a lower extremity wound. 2. Presence of another wound within the boundaries of the target wound; especially if it is being concurrently treated and may interfere with the wound applicable for this study. 3. Presence of a clinically confirmed, infected wound, thereby requiring antibiotics. The presence of infection is defined by ≥ 2 classic findings of inflammation (erythema, warmth, tenderness, pain, or induration) or purulent secretions (Lipsky et al, 2012). 4. Hemoglobin of less than 10.5 g/dL. 5. Serum Albumin of less than 2.5 g/dL. 6. Plasma Platelet count of less than 100 x 109/L. 7. Inadequate amount of blood drawn to produce sufficient PRFM. One complete PRFM preparation requires 10ml of blood drawn. 8. Target ulcer area decreases by ≥ 20% prior to and/or during 2-week screening/run-in period. 9. Subject's target ulcer has tunnels or sinus tracts that cannot be completely debrided. 10. Subject's target ulcer exposes tendon or bone. 11. Subject has inadequate venous access for repeated blood draw required for centrifugation and completion of the treatment procedures. 12. Subject has severe malnutrition as evidenced by mNA score \