NCT07318792

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).

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Estar Medical dba Medical Technologies, LTD · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wound Chronic Draining
• Wound Closure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-09-15
• Completion: 2026-12-01
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study