RecruitingPhase 2NCT06810726

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)


Sponsor

Estar Medical dba Medical Technologies, LTD

Enrollment

30 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating Tropocells, a product made from a patient's own blood (platelet-rich fibrin), to see if it helps wounds heal — particularly in difficult-to-heal wounds or surgical sites. Because the material comes from your own body, there is no risk of rejection. **You may be eligible if...** - You have a wound or surgical site that is not healing well - You are being considered for a wound treatment procedure - You meet the age and health requirements of the trial **You may NOT be eligible if...** - You have blood clotting disorders that make platelet-rich fibrin preparation unsafe - You are on blood-thinning medications that would interfere with the process - You have active infections at the wound site that need to be treated first Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPlatelet Rich Plasma

Tropocells(R) Autologous Platelet-Rich Fibrin


Locations(2)

WoundCentrics Wound Care & Hyperbarics -Corpus Christi - Shoreline

Corpus Christi, Texas, United States

Woundcentrics Wound Care Center At Corpus Christi South

Corpus Christi, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06810726


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