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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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.

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)

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. (NCT06810726) is a Phase 2 interventional studying Diabetic Foot Ulcer and Type 1 Diabetes Mellitus, sponsored by Estar Medical dba Medical Technologies, LTD. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Diabetic Foot Ulcer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

Platelet Rich Plasma

Tropocells(R) Autologous Platelet-Rich Fibrin

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

WoundCentrics Wound Care & Hyperbarics -Corpus Christi - Shoreline
Corpus Christi, Texas, United States
Woundcentrics Wound Care Center At Corpus Christi South
Corpus Christi, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06810726), the sponsor (Estar Medical dba Medical Technologies, LTD), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06810726 clinical trial studying?

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 … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06810726?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06810726?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06810726. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06810726. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.