Tropocells autologous platelet-rich fibrin for healing mild-to-moderate neuroischemic diabetic foot ulcers

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)

This will test whether Tropocells autologous platelet-rich fibrin (PRF) helps close mild-to-moderate neuroischemic diabetic foot ulcers in adults with type 1 or type 2 diabetes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Estar Medical dba Medical Technologies, LTD (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Corpus Christi, Texas and 1 other locations)
• Trial ID: NCT06810726 on ClinicalTrials.gov

What this trial studies

Adults with diabetic plantar ulcers first undergo a 2-week run-in with standard wound care, and patients whose wounds do not shrink by at least 20% may enter a 12-week active phase with weekly clinic visits. During the active phase, a PRF gel clot made from the patient’s own blood is applied to the wound after cleansing and debridement in addition to standard dressings and off-loading. The single-arm Phase 2 trial plans to enroll about 30 evaluable subjects and will track complete wound closure as the primary outcome and adverse events as safety endpoints. Subjects with complete closure are reassessed at 1 and 3 months to monitor sustained healing.

Who should consider this trial

Good fit: Adults (≥18 years) with type 1 or type 2 diabetes who have a noninfected Wagner grade 1–2 neuroischemic plantar foot ulcer 1.0–12.0 cm2 present at least 30 days, with adequate limb perfusion (ABI, toe pressure, TcPO2, or SPP meeting study thresholds) are the intended candidates.

Not a fit: Patients with infected ulcers, exposed bone/tendon, tunneling or undermining, ulcers between the toes, wounds outside the 1.0–12.0 cm2 range, inadequate vascular perfusion, or other contraindications are unlikely to qualify or benefit from this treatment.

Why it matters

Potential benefit: If successful, the treatment could speed wound closure and reduce the time a diabetic foot ulcer remains open, potentially lowering infection and amputation risk.

How similar studies have performed: Small randomized and nonrandomized studies of platelet-rich products (PRP/PRF) for diabetic foot ulcers have reported mixed but sometimes promising results, though high-quality, consistent evidence remains limited.

Eligibility criteria

Inclusion Criteria:

1. Male or female ≥ 18 years of age
2. Type 1 or Type 2 Diabetes
3. Grade 2, DFU, non-infected, below the ankle,1.0-12.0 cm2, present ≥ 30 day
4. Ulcer Size 1.0 cm2 to 12.0 cm2
5. 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
6. If more than one non-healing wound is present, the selected ulcer will be the largest and ≥ 1 cm2 in size.
7. At least 2.0 cm between the index wound and other wounds.
8. Study ulcer has been present for at least 30 days and has undergone the 14-day
9. 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.
10. WIFI SCORE- wound grade 1, ischemia grade 0-1, and infection grade 0)
11. Screening Period of the standard of care with 20% or less wound closure.
12. No Clinical Signs of Infection at the wound site or the affected limb.
13. Post-debridement without signs of necrotic tissue.
14. Normal Platelet count ≥ 105,000 and \<450, 000 (according to CBC)
15. Hemoglobin (Hgb) ≥10 g/dL and Hematocrit (HCT) ≥ 27% (according to CBC)
16. Controlled glucose level HbA1C ≤ 12%, with active treatment being conducted to reduce the value to by a primary provider or endocrinologist
17. No Chronic Renal Failure (CRF); Estimated glomerular filtration rate (eGFR) ≥ 15
18. PT/PTT - INR between 2.0-3.0 (with blood thinners).
19. Nutritional Status with no severe protein deficiency, Pre-albumen \>15 mg/dL
20. Demonstrated adequate offloading using DH Walker boot with Plastazote Insole (OR equivalent off-loading device).
21. If a female of childbearing potential, must have a negative serum or urine pregnancy test at screening and use contraception or abstinence during trial.
22. Male subjects agree to use contraception or abstinence during the trial.
23. The subject has provided written informed consent before any screening procedures and agrees to comply with study procedures and requirements.

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.

Where this trial is running

Corpus Christi, Texas and 1 other locations

• WoundCentrics Wound Care & Hyperbarics -Corpus Christi - Shoreline — Corpus Christi, Texas, United States (Recruiting)
• Woundcentrics Wound Care Center At Corpus Christi South — Corpus Christi, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Marcus L. Gitterle, MD — WoundCentrics
• Study coordinator: Marcus L. Gitterle, MD, FACCWS

Conditions Diabetic Foot Ulcer; Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus; Neuroischemic Foot Ulcer; Chronic Wound of the Lower Limb; Chronic Wound Care; PRF used for Wagner Grade 2 DFU; Tropocells Platelet-rich Fibrin