EVALUATION OF THE SAFETY AND THE CLINICAL PERFORMANCE IN TREATMENT OF CHRONIC DIABETIC FOOT ULCER, WITH THE TROPOCELLS®, BASED AUTOLOGOUS PLATELET RICH FIBRIN (Tropocells(R) Autologous PRF Systems)
The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2, mild to moderate, neuroischemic diabetic chronic foot ulcers in subjects with Type 1 and Type 2 Diabetes Mellitus. The main question\[s\] it aims to answer \[is/are\]: Measure 1: Wound Closure with Tropocells Autologous PRF System for DFU Measure 2: Safety of Tropocells Autologous PRF System for DFU Researchers will enroll to acquire approximately 30 evaluable subjects with no comparison group. Run-In Phase (2 weeks): participants with chronic diabetic foot wounds will undergo a 2-week run in phase presenting to the clinic for weekly visits, for standard of care. Active Treatment Phase (12 weeks): participants that do not show a reduction of at least 20% may be qualified to advance to the active treatment phase where wounds will be evaluated and treated weekly in the research clinic to receive standard of care with Tropocells Autologous PRF System. Follow-up Phase (1 month and 3 months): participants with wounds that losed during the Active Treatment Phase ( 100% wound closure with two weekly assessments demonstrating persistent closure) will be advanced to the follow-up phase to show if the wound remains closed at 1 month and 3 months.
• Male or female ≥ 18 years of age
• Type 1 or Type 2 Diabetes
• Grade 2, DFU, non-infected, below the ankle,1.0-12.0 cm2, present ≥ 30 day
• Ulcer Size 1.0 cm2 to 12.0 cm2
• Wound location will be distal to the malleolus, excluding between the toes, with no exposed capsule, tendon, or bone, and no tunneling, undermining, or sinus tracts, a depth of ≤ 5mm
• If more than one non-healing wound is present, the selected ulcer will be the largest and ≥ 1 cm2 in size.
• At least 2.0 cm between the index wound and other wounds.
• Study ulcer has been present for at least 30 days and has undergone the 14-day
• Adequate vascular perfusion of the affected limb, as defined by at least one of the following: Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2, Toe Pressure (TP) ≥ 30 mmHg, Transcutaneous partial pressure of oxygen (TcPO2) ≥ 30 mmHg, or skin perfusion pressure (SPP) ≥ 30 mmHg.
⁃ WIFI SCORE- wound grade 1, ischemia grade 0-1, and infection grade 0)
⁃ Screening Period of the standard of care with 20% or less wound closure.
⁃ No Clinical Signs of Infection at the wound site or the affected limb.
⁃ Post-debridement without signs of necrotic tissue.
⁃ Normal Platelet count ≥ 105,000 and \<450, 000 (according to CBC)
⁃ Hemoglobin (Hgb) ≥10 g/dL and Hematocrit (HCT) ≥ 27% (according to CBC)
⁃ Controlled glucose level HbA1C ≤ 12%, with active treatment being conducted to reduce the value to by a primary provider or endocrinologist
⁃ No Chronic Renal Failure (CRF); Estimated glomerular filtration rate (eGFR) ≥ 15
⁃ PT/PTT - INR between 2.0-3.0 (with blood thinners).
⁃ Nutritional Status with no severe protein deficiency, Pre-albumen \>15 mg/dL
⁃ Demonstrated adequate offloading using DH Walker boot with Plastazote Insole (OR equivalent off-loading device).
⁃ If a female of childbearing potential, must have a negative serum or urine pregnancy test at screening and use contraception or abstinence during trial.
⁃ Male subjects agree to use contraception or abstinence during the trial.
⁃ The subject has provided written informed consent before any screening procedures and agrees to comply with study procedures and requirements.