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

NCT07318792 | Not Yet Recruiting Phase 2 DMC FDA Device

• 1 other identifier: RND054- AIM II Chronic Wounds
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Wound Chronic Draining; Wound Closure

Keywords

Chronic Non-healing Wounds; TropoCells(R) Platelet-rich Fibrin (PRF); Autologous Platelet-rich Fibrin (PRF); Platelet Derived Therapy

Outcome Measures

Primary Outcomes (1)

• Complete Wound Closure

  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

Study Arms (1)

Participants with non-infected, mild-to-moderate, chronic open soft tissue wound

ACTIVE COMPARATOR

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)

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

Participants with non-infected, mild-to-moderate, chronic open soft tissue wound

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. Documented 40% or less wound closure during thirty (30) days of standard of care (SOC).
• \. 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.
• \. Prealbumin ≥ 15 mg/dL. 17. Adequate off-loading of the wound site for wheelchair bound, bed bound, and ambulatory subjects.
• \. 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.
• \. 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.
• \. Usual care therapies that may be included will be negative pressure wound therapy (NPWT), antimicrobial dressings, collagen containing matrix and packing materials.

You may not qualify if:

• Life expectancy is less than twelve (12) months.
• Participation in another clinical trial involving an investigational device or drug within thirty (30) days prior to enrollment.
• Sepsis within two (2) weeks prior to enrollment.
• Soft tissue infection affecting the wound within two (2) weeks prior to enrollment.
• Known osteomyelitis or occult osteomyelitis documented with inflammatory markers ESR ≥ 60 and/or CRP ≥7.9 mg/dL.
• Religious constraints to using blood products, including autologous blood.
• Alcohol or substance abuse (other than tobacco) within 2 months prior.
• Severe lymphedema at Stage 3b or greater (lymphostatic elephantiasis).
• The inability to use compression therapy for venous insufficiency or lymphedema.
• Subjects who are cognitively impaired, unable to understand the informed consent, or have a health care proxy.
• Hemophilia, sickle cell anemia, thrombocytopenia, and leukemia or blood dyscrasia.
• 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.
• Cytostatic therapy within the past 12 months.
• The subject has inadequate venous access for repeated blood draw.
• Known HBV, HCV, or HIV.

Sponsors & Collaborators

• Estar Medical dba Medical Technologies, LTD: lead
• Global Clinical Research Institute: collaborator

Study Sites (3)

MCR Health-Advanced Specialty Institute (ASI)

Bradenton, Florida, 34209, United States

Location

San Antonio Vascular and Endovascular Clinic (SAVE)

San Antonio, Texas, 78221, United States

Location

The San Antonio Vascular and Endovascular Clinic (SAVE)

San Antonio, Texas, 78221, United States

Location

Related Publications (5)

• Bolton L. Platelet-Rich Plasma: Optimal Use in Surgical Wounds. Wounds. 2021 Aug;33(8):219-221.

  PMID: 34357880 BACKGROUND

• Milek T, Nagraba L, Mitek T, Wozniak W, Mlosek K, Olszewski W, Ciostek P, Deszczynski J, Kuchar E, Stolarczyk A. Autologous Platelet-Rich Plasma Reduces Healing Time of Chronic Venous Leg Ulcers: A Prospective Observational Study. Adv Exp Med Biol. 2019;1176:109-117. doi: 10.1007/5584_2019_388.

  PMID: 31134552 BACKGROUND

• Qu W, Wang Z, Hunt C, Morrow AS, Urtecho M, Amin M, Shah S, Hasan B, Abd-Rabu R, Ashmore Z, Kubrova E, Prokop LJ, Murad MH. The Effectiveness and Safety of Platelet-Rich Plasma for Chronic Wounds: A Systematic Review and Meta-analysis. Mayo Clin Proc. 2021 Sep;96(9):2407-2417. doi: 10.1016/j.mayocp.2021.01.030. Epub 2021 Jul 3.

  PMID: 34226023 BACKGROUND

• Meznerics FA, Fehervari P, Dembrovszky F, Kovacs KD, Kemeny LV, Csupor D, Hegyi P, Banvolgyi A. Platelet-Rich Plasma in Chronic Wound Management: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. J Clin Med. 2022 Dec 19;11(24):7532. doi: 10.3390/jcm11247532.

  PMID: 36556151 BACKGROUND

• 1. Wounds International: White paper on wound balance - Achieving wound healing with confidence (2023), https://woundsinternational.com/wp-content/uploads/2023/04/HAR23_Supp_Wound-Balance_WINT-Web.pdf.

  BACKGROUND

Central Study Contacts

Adrianne P Smith, MD

CONTACT

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

Morgan Zelen, CCRC

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: No parties are masked
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Non-randomized, Single group

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 6, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

US (3)