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

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).

NCT07318792•Estar Medical dba Medical Technologies, LTD

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Summary

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.

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.
+1 more 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.
+9 more criteria

Locations (3)

MCR Health-Advanced Specialty Institute (ASI)

Bradenton, Florida, United States

San Antonio Vascular and Endovascular Clinic (SAVE)

San Antonio, Texas, United States

The San Antonio Vascular and Endovascular Clinic (SAVE)

San Antonio, Texas, United States

Key Dates

Start Date

January 1, 2026

Primary Completion Date

September 15, 2026

Completion Date

December 1, 2026

Last Updated

January 6, 2026

Enrollment

ESTIMATED participants

Conditions

Wound Chronic DrainingWound Closure

Interventions

Platelet-rich fibrin (PRF)

DEVICE

Contacts

Adrianne P Smith, MD

CONTACT

210-807-2589 p.smithmd@sanogenix.com

Morgan Zelen, CCRC

CONTACT

203-671-5915 morganz@gcri-cro.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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