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.

June 10, 2025 updated by: Estar Medical dba Medical Technologies, LTD

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Corpus Christi, Texas, United States, 78404
      • Corpus Christi, Texas, United States, 78414

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T1DM,T2DM participants with non-infected, neuroischemic, chronic foot ulcers
During Screen-the participant will be treated with standard of care (SOC) for 2 weeks, including education, nutritional supplement, weekly wound assessments and care with off-loading. After the two weekly visits, subjects who meet the inclusion/exclusion criterion, show adequate perfusion and area reduction less than 20%, and comply with the standard of care will be enrolled in the Active Treatment Phase. During the Active Treatment Phase, subjects will be treated weekly with TropoCells® Autologous Platelet-rich Fibrin (PRF) for twelve (12) weeks and continued SOC. Wound area will be documented with measures and photographs before and after cleansing and debridement (as needed). Clean wounds treated topically with active therapy will be covered with a non-adherent layered absorbent foam dressing with an external protective third layer. Mild compression will be applied with continued off-loading at least 2 week after closure. Follow-up evaluation after closure at 1 and 3 months.
Device: Platelet Rich Plasma
Tropocells(R) Autologous Platelet-Rich Fibrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete wound closure
Time Frame: 12 weeks of active therapy weekly applications
  • An independent validation will be performed by an independent wound care specialist who will determine if the wound is fully closed, demonstrating 100% re-epithelialization persisting for two (2) subsequent weekly assessments. The validation will be reviewed with the treating researcher and the PI to formalize the results reported to the biostatistician for analysis. The biostatistician will perform and report the following analysis.
  • Number of subjects achieving complete epithelialization at 12 weeks in the Intent to Treat (ITT) population.
  • Number of subjects achieving complete epithelialization at 12 weeks in the Per Protocol (PP) population.
12 weeks of active therapy weekly applications

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety- Adverse Events, Serious Adverse Events, Deviations, Violations
Time Frame: Screening Phase- 2 weeks and Active Treatment Phase- 12 weeks

The biostatistician will measure and report:

  1. Adverse Events (AE), including any untoward or unfavorable medical occurrence in a human study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with a participant's involvement in the research, whether or not considered related to participation in the research, and
  2. Serious Adverse Events (SAE), including any adverse event that: i) results in death, ii) is life-threatening, or places the participant at immediate risk of death from the event as it occurred, iii) requires or prolongs hospitalization, iv) causes persistent or significant disability or incapacity,and/o v) results in congenital anomalies or birth defects vi) Is another condition which in the investigator's judge to represent significant hazards, and 3) Unanticipated Problem (UP):

Defined by DHHS 45 CFR part 46 as any incident, experience, or outcome that meets the criteria.
Screening Phase- 2 weeks and Active Treatment Phase- 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Area Reduction (PAR)
Time Frame: 12 weeks
percent wound closure compared to baseline (beginning Active Treatment Phase) to complete wound closure performing assessments every two weeks during the Active Treatment Phase (weeks: 2, 4, 6, 8, 10, and 12).
12 weeks
Time to Wound Closure
Time Frame: 12 weeks
Active Phase week (0) will be compared to the week of closure. All weeks will be followed for 2 weekly visits after closure. Closure noted at the last Active Phase visit will be followed for 2 additional weeks to ensure proper documentation of closure.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Estar Medical dba Medical Technologies, LTD

Collaborators

WCG IRB

Investigators

  • Principal Investigator: Marcus L. Gitterle, MD, WoundCentrics
  • Study Director: Adrianne P Smith, MD, Sanogenix Medical, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

August 15, 2026

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

February 4, 2025

First Posted (Actual)

February 6, 2025

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RND054-Tropocells PRF for DFU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual patient data (IPD) will be shared with the organizations used to analyze the data (Strategic Solutions, Inc) and to present the data to the FDA/CBER for the 510K Submission.

IPD Sharing Time Frame

Anticipated 510K submission- Jul2026 Duration while 510K is under consideration- 90 days

IPD Sharing Access Criteria

The clinical research organization, Global Clinical Research Institute-GCRI), and biostatistician (Strategic Solutions, Inc.), regulatory consultant, Biologics Consulting Group-BCG,and the WCG IRB will be able to access the data in deidentified format and potentially as individual patient data (IPD) during trial conduct or in preparation for the 510K submission.

If the FDA clears the device, we may publish the results to share with the medical community; however, only deidentified case studies and/or analyzed data will be used.

IPD may also be shared with other researchers in a registry once the device has been cleared.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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