Overview
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.
Description
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, where they will receive standard of care Including-
- nutritional supplementation for 2 weeks,
- wound assessment with photos and measurements,
- wound care including cleansing and debridement,
- wound dressings,
- mild compression of the lower extremity, and
- off-loading with a removable boot.
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. In addition to standard of care, Tropocells Autologous PRF Systems gel clot will be placed on the wound bed after cleansing and debridement prior to wound dressing and off-loading.
Data will be captured for:
Primary Outcome- Clinical Performance with complete wound closure, and Secondary Outcome(s)-
- Safety assessing adverse events (AE) and severe adverse events (SAE),
- Measures of Clinical Performance including,
- trajectory of wound area reduction
- percent (%) of area reduction,
- proportion of wound area reduction
Follow-up Phase (1 month and 3 months): participants that have 100% wound closure with two weekly assessments demonstrating persistent closure, will be advanced to the follow-up phase, where they will be assessed at 1 month and 3 months with photos and measurements to show if they remain closed.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Life expectancy is less than 12 months.
- Anemia Hgb ≤ 10 g/dL and HCT ≤ 27%.
- Ulcers of other than diabetic foot pathophysiology.
- Participation in another clinical trial involving a device or a systematically administered investigational study drug or treatment within 30 days.
- Documented sepsis, proven with blood cultures, within 2 weeks of the trial or during the Screening Phase.
- Soft tissue infection at the designated ulcer or the same extremity within 2 weeks of the time of screening.
- Osteomyelitis at the designated wound site; using ESR ≥ and /or CRP ≥ 7.9 mg/d as a screen.
- CKD Level G5: Chronic Renal Failure (CRF) sufficient to require dialysis.
- Religious constraints to using blood products, including autologous blood.
- Alcohol or substance abuse (other than tobacco) within 2 months before enrollment.
- Blood-borne or communicable diseases that would likely prevent full participation in the trial (e.g., HIV, AIDs, COVID, TB).
- Participation in another clinical trial involving a device or a systematically administered investigational study drug or treatment within 30 days of initiating the trial.
- 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.
- The subject is undergoing hemodialysis.
- Subjects who are cognitively impaired, unable to understand the informed consent, or have a health care proxy.
- Subjects with sickle cell anemia, thrombocytopenia, leukemia, or blood dyscrasia.
- 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.
- Anemia where weekly blood draws of 12 or 23 per week may not be tolerated.
- Received electrostimulation, hyperbaric treatments, growth factors, or any cell or tissue-derived therapy for any wounds 30 days before entry into the study.
- Systemic corticosteroids, (except for subjects receiving inhaled corticosteroid treatments for asthma or COPD) 30 days before entry into the study.
- 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.
- Received radiation therapy or chemotherapy within the previous 3 months.
- Subjects with known sensitivity to blood components such as those in the PRF kit.
- The subject has inadequate venous access for repeated blood draws required for the PRP preparation.