NCT06810726

Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.

EVALUATION OF THE SAFETY AND THE CLINICAL PERFORMANCE IN TREATMENT OF CHRONIC DIABETIC FOOT ULCER, WITH THE TROPOCELLS®, BASED AUTOLOGOUS PLATELET RICH FIBRIN (Tropocells(R) Autologous PRF Systems)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Estar Medical dba Medical Technologies, LTD · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2, mild to moderate, neuroischemic diabetic chronic foot ulcers in subjects with Type 1 and Type 2 Diabetes Mellitus. The main question\[s\] it aims to answer \[is/are\]: Measure 1: Wound Closure with Tropocells Autologous PRF System for DFU Measure 2: Safety of Tropocells Autologous PRF System for DFU Researchers will enroll to acquire approximately 30 evaluable subjects with no comparison group. Run-In Phase (2 weeks): participants with chronic diabetic foot wounds will undergo a 2-week run in phase presenting to the clinic for weekly visits, for standard of care. Active Treatment Phase (12 weeks): participants that do not show a reduction of at least 20% may be qualified to advance to the active treatment phase where wounds will be evaluated and treated weekly in the research clinic to receive standard of care with Tropocells Autologous PRF System. Follow-up Phase (1 month and 3 months): participants with wounds that losed during the Active Treatment Phase ( 100% wound closure with two weekly assessments demonstrating persistent closure) will be advanced to the follow-up phase to show if the wound remains closed at 1 month and 3 months.

Detailed description

Run-In Phase (2 weeks): participants with chronic diabetic foot wounds will undergo a 2-week run in phase presenting to the clinic for weekly visits, where they will receive standard of care Including- * nutritional supplementation for 2 weeks, * wound assessment with photos and measurements, * wound care including cleansing and debridement, * wound dressings, * mild compression of the lower extremity, and * off-loading with a removable boot. Active Treatment Phase (12 weeks): participants that do not show a reduction of at least 20% may be qualified to advance to the active treatment phase where wounds will be evaluated and treated weekly in the research clinic. In addition to standard of care, Tropocells Autologous PRF Systems gel clot will be placed on the wound bed after cleansing and debridement prior to wound dressing and off-loading. Data will be captured for: Primary Outcome- Clinical Performance with complete wound closure, and Secondary Outcome(s)- * Safety assessing adverse events (AE) and severe adverse events (SAE), * Measures of Clinical Performance including, * trajectory of wound area reduction * percent (%) of area reduction, * proportion of wound area reduction Follow-up Phase (1 month and 3 months): participants that have 100% wound closure with two weekly assessments demonstrating persistent closure, will be advanced to the follow-up phase, where they will be assessed at 1 month and 3 months with photos and measurements to show if they remain closed.

Conditions

• Diabetic Foot Ulcer
• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus (T2DM)
• Neuroischemic Foot Ulcer
• Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
• Chronic Wound Care

Interventions

Type	Name	Description
DEVICE	Platelet Rich Plasma	Tropocells(R) Autologous Platelet-Rich Fibrin

Timeline

• Start date: 2025-04-15
• Primary completion: 2026-05-15
• Completion: 2026-08-15
• First posted: 2025-02-06
• Last updated: 2025-06-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study