Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.

Exclusion Criteria

• •1. Life expectancy is less than 12 months.
• •2. Anemia Hgb ≤ 10 g/dL and HCT ≤ 27%.
• •3. Ulcers of other than diabetic foot pathophysiology.
• •4. Participation in another clinical trial involving a device or a systematically administered investigational study drug or treatment within 30 days.
• •5. Documented sepsis, proven with blood cultures, within 2 weeks of the trial or during the Screening Phase.
• •6. Soft tissue infection at the designated ulcer or the same extremity within 2 weeks of the time of screening.
• •7. Osteomyelitis at the designated wound site; using ESR ≥ and /or CRP ≥ 7.9 mg/d as a screen.
• •8. CKD Level G5: Chronic Renal Failure (CRF) sufficient to require dialysis.
• •9. Religious constraints to using blood products, including autologous blood.
• •10. Alcohol or substance abuse (other than tobacco) within 2 months before enrollment.
• •11. Blood-borne or communicable diseases that would likely prevent full participation in the trial (e.g., HIV, AIDs, COVID, TB).
• •12. Participation in another clinical trial involving a device or a systematically administered investigational study drug or treatment within 30 days of initiating the trial.
• •13. The subject has severe lymphedema (Stage 3) where the individual cannot lift the extremity on their own secondary to the amount of edema and fluid weight.
• •14. The subject is undergoing hemodialysis.
• •15. Subjects who are cognitively impaired, unable to understand the informed consent, or have a health care proxy.
• •16. Subjects with sickle cell anemia, thrombocytopenia, leukemia, or blood dyscrasia.
• •17. History of problems with coagulation, abnormal thrombocytes (platelets), or receiving heparin intravenously; subjects taking coumadin, aspirin, clopidogrel, or other oral anti-coagulants are not excluded.
• •18. Anemia where weekly blood draws of 12 or 23 per week may not be tolerated.
• •19. Received electrostimulation, hyperbaric treatments, growth factors, or any cell or tissue-derived therapy for any wounds 30 days before entry into the study.
• •20. Systemic corticosteroids, (except for subjects receiving inhaled corticosteroid treatments for asthma or COPD) 30 days before entry into the study.
• •21. Received within 30 days before the study or scheduled to receive medications or treatments known to interfere with or affect the rate or quality of wound closure (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy within the past 12 months, dialysis, radiation therapy to the treatment area, vascular surgery, angioplasty, or thrombolysis.
• •22. Received radiation therapy or chemotherapy within the previous 3 months.
• •23. Subjects with known sensitivity to blood components such as those in the PRF kit.
• •24. The subject has inadequate venous access for repeated blood draws required for the PRP preparation.