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

Part of paid clinical trials in Bradenton, Florida.

Sponsor
Estar Medical dba Medical Technologies, LTD
Study ID
NCT07318792
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Wound Chronic Draining
  • Wound Closure

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Platelet-rich fibrin (PRF) — DEVICE
    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

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
Jan 2026
Primary completion
Sep 15, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Complete Wound Closure [ Time Frame: From Screening to end of follow-up at 9 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
MCR Health-Advanced Specialty Institute (ASI)BradentonFlorida34209
Chrisbel N Dafeamekpor, DPM
[email protected]
941-304-3971
Evelyn Perez, CRA
[email protected]
941-304-9885
Elizabeth Knight, APRN (SUB_INVESTIGATOR)
San Antonio Vascular and Endovascular Clinic (SAVE)San AntonioTexas78221-
The San Antonio Vascular and Endovascular Clinic (SAVE)San AntonioTexas78221
Elizabeth Knight, CCRC
[email protected]
941-304-3971
Nolan Payton, CCRC
[email protected]
409-550-3145
Lyssa N Ochoa, MD (PRINCIPAL_INVESTIGATOR)
Allen Hartsell, MD (SUB_INVESTIGATOR)
Monica Kincade, APRN (SUB_INVESTIGATOR)

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By research site
MCR Health-Advanced Specialty Institute (ASI)· Bradenton, FLSan Antonio Vascular and Endovascular Clinic (SAVE)· San Antonio, TXThe San Antonio Vascular and Endovascular Clinic (SAVE)· San Antonio, TX

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