Using TropoCells(R) Autologous Platelet-Rich Fibrin (PRF) to Treat Chronic Non-Healing Wounds

January 4, 2026 updated by: Estar Medical dba Medical Technologies, LTD

Evaluation of the Safety and the Clinical Effectiveness of Using Tropocells® Autologous PRF System to Treat Chronic, Non-healing, Non-infected Wounds in Combination With Standard of Care (SOC).

Platelet-based therapies have been used to treat bony and soft tissue effects for more than 30 years. Tropocells® Autologous Platelet-Rich Fibrin (PRF) is being used to treat chronic, non-healing wounds, of a variety of types. This will help determine the safety and effective use of PRF in the treatment of soft tissue defects.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic wounds are wounds that fail to progress through a normal healing process in a timely fashion. Typically the wounds remain in a pro-inflammatory state. The activation of platelets reacting to tissue damage initiates most healing sequences. The use of activated platelets in the form or platelet-rich plasma (PRP) and/or platelet-rich fibrin (PRF) applied to a clean wound base has been associated with improved wound healing outcomes for bony and soft tissues, especially when associated with standard of care (SOC), including supporting underlying medical conditions, improved perfusion and oxygenation, edema control, removing recurrent insults for trauma, treating infection, and preventing ongoing inflammatory triggers. Activated platelets in the form of Tropocells(R) autologous platelet-rich fibrin (PRF) made from "blood drawn from peripheral veins, and centrifuged into a gel, topically applied to exuding cutaneous wounds such as leg ulcers, pressure ulcers and diabetic ulcers, and mechanically or surgically-debrided wounds." Sixteen (16) Subjects will be enrolled to evaluate the efficacy and safety when used to treat chronic noninfected, nonhealing, mild to moderately ischemic wounds.

Study Type

Interventional

Enrollment (Estimated)

16

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
    • Florida
      • Bradenton, Florida, United States, 34209
        • MCR Health-Advanced Specialty Institute (ASI)
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Elizabeth Knight, APRN
    • Texas
      • San Antonio, Texas, United States, 78221
        • San Antonio Vascular and Endovascular Clinic (SAVE)
      • San Antonio, Texas, United States, 78221
        • The San Antonio Vascular and Endovascular Clinic (SAVE)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lyssa N Ochoa, MD
        • Sub-Investigator:
          • Allen Hartsell, MD
        • Sub-Investigator:
          • Monica Kincade, APRN

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≤ 80 years of age 2. Chronic wounds present for at least thirty (30) days meeting classification as, mild to moderate severity, open exuding wound, including, leg ulcer, pressure ulcer, or mechanically or surgically debrided.

    3. Located in any anatomical location on the body. 4. If more than one non-healing wound is present, an index wound will be selected ≥ 1.0 cm2 size and less than or equal to 25.0 cm2.

    5. If the wound is in an ulcer cluster the dominant ulcer will be selected, with at least 2.0 cm2 between the index wound and other wounds.

    6. The study wound will be present for at least thirty (30) days and the subject will have undergone standard of care assessment and intervention, according to the wound type being evaluated, where SOC may include, but not be limited to, proper cleansing and debridement, off-loading, compression, bioburden reduction, moisture management, infection control, optimized perfusion, venous ablation, nutrition supplementation, smoking cessation counseling and medical therapy, and access to wound and underlying disease education and training.

    7. Neurovascular assessment, conducted according to the assessment typically performed for the wound type will be performed during Screening (Study Visit 1), and repeated at the level normally conducted at the follow-up visits. Perfusion should be adequate to sustain a healing process. Neurological examinations will be performed to document the presence of neuropathy and/or nerve injury.

    8. Documented 40% or less wound closure during thirty (30) days of standard of care (SOC).

    9. No clinical signs of infection at the wound site or the affected limb. 10. Post-debridement with no residual necrotic tissue. 11. Platelet counts should be within normal range ≥ 105,000 to <450, 000. 12. Hemoglobin (Hgb) ≥ 10 g/dL and Hematocrit (HCT) ≥ 27%. 13. HbA1C ≤ 12%. 14. Chronic renal failure (CRF) and dialysis patients may be enrolled. 15. PT/aPTT/INR should be within normal limits unless the subject is on coumadin, then maintain range of INR 2 to 3.

    16. Prealbumin ≥ 15 mg/dL. 17. Adequate off-loading of the wound site for wheelchair bound, bed bound, and ambulatory subjects.

    18. Multi-layered compression dressings for venous related wounds. 19. Females of childbearing potential should not be pregnant and agree to avoid conceiving during the study.

    20. Males agree to use contraception or abstinence during the study. 21. The subject has provided written informed consent prior to any screening procedures and agrees to comply with study procedures and requirements.

    22. Usual care therapies that may be included will be negative pressure wound therapy (NPWT), antimicrobial dressings, collagen containing matrix and packing materials.

Exclusion Criteria:

  • Exclusion Criteria

    1. Life expectancy is less than twelve (12) months.
    2. Participation in another clinical trial involving an investigational device or drug within thirty (30) days prior to enrollment.
    3. Sepsis within two (2) weeks prior to enrollment.
    4. Soft tissue infection affecting the wound within two (2) weeks prior to enrollment.
    5. Known osteomyelitis or occult osteomyelitis documented with inflammatory markers ESR ≥ 60 and/or CRP ≥7.9 mg/dL.
    6. Religious constraints to using blood products, including autologous blood.
    7. Alcohol or substance abuse (other than tobacco) within 2 months prior.
    8. Severe lymphedema at Stage 3b or greater (lymphostatic elephantiasis).
    9. The inability to use compression therapy for venous insufficiency or lymphedema.
    10. Subjects who are cognitively impaired, unable to understand the informed consent, or have a health care proxy.
    11. Hemophilia, sickle cell anemia, thrombocytopenia, and leukemia or blood dyscrasia.
    12. History of problems with coagulation, abnormal thrombocytes (platelets), or receiving heparin, intravenously. However, subjects taking coumadin, aspirin, clopidogrel, or other oral anti-coagulants are not excluded.
    13. Cytostatic therapy within the past 12 months.
    14. The subject has inadequate venous access for repeated blood draw.
    15. Known HBV, HCV, or HIV.
    16. Blood-borne or communicable disease that would likely prevent full participation in the trial (HIV, AIDS, COVID-19).
    17. Subjects with known sensitivity to blood components of the PRF Kit (e.g., rubber stopper, vacutainer tubing).
    18. Advanced therapy treatments with hyperbaric oxygen, electrical stimulation (eStim), pulsed electromagnetic energy fields (PEMF), colored light therapies, cellular tissue products (CTPs) like amniotic tissues, Apligraf® and Dermagraft® will be excluded; while NPWT, collagen matrix products (sheet or bulk packing), antimicrobial dressings (surfactants, silver or copper, hypochlorous acid) may be used.

AIDS- acquired immunodeficiency syndrome; COPD-chronic obstructive pulmonary disease; COVID-19- Coronavirus Disease-19; CRP- C-reactive protein; ESR-erythrocyte sedimentation rate; HBV-hepatitis B virus; HCV- hepatitis C virus; HIV- human immune-deficiency virus.

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
Active Comparator: Participants with non-infected, mild-to-moderate, chronic open soft tissue wound
Tropocells® Autologous Platelet-Rich Fibrin (PRF) to be topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically debrided wounds", intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient's own peripheral blood. Under the supervision of a healthcare professional.
Device: Platelet-rich fibrin (PRF)

Standard of Care will include-

  1. Nutritional Supplementation using 14 days Juven(R)
  2. Wound Cleansing and Debridement
  3. Mild to Moderate Compression as needed for edema Control
  4. Off-loading as needed (foot gear, chair cushions, bed mattresses)
  5. Antimicrobial Dressings as needed
  6. Edema Control
  7. Negative Pressure Wound Therapy- as needed
  8. Collagen dressings as indicated
  9. Optimized perfusion/oxygenation
  10. Treated Underlying Medical Conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Wound Closure
Time Frame: From Screening to end of follow-up at 9 weeks

Number of Subjects with Complete Wound Closure- defined as 100% re-epithelialization remaining closed during two (2) consecutive weekly follow-up assessments.

  • Intent-to-treat analysis
  • Per-protocol analysis
From Screening to end of follow-up at 9 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

Global Clinical Research Institute

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 (Estimated)

January 1, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 4, 2026

First Submitted That Met QC Criteria

January 4, 2026

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RND054- AIM II Chronic Wounds

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual Participant Data will be shared with the FDA in support of the IDE, if required. There is no plan to share IPD with journals or publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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