NCT06810726 · Estar Medical dba Medical Technologies, LTD
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.
What this study is about
The goal of this experimental 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.
View original scientific description
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.
Interventions
DEVICE
Platelet Rich Plasma
Tropocells(R) Autologous Platelet-Rich Fibrin
Primary outcome measures
Complete wound closure
Time frame: 12 weeks of active therapy weekly applications
* An independent validation will be performed by an independent wound care specialist who will determine if the wound is fully closed, demonstrating 100% re-epithelialization persisting for two (2) subsequent weekly assessments. The validation will be reviewed with the treating researcher and the PI to formalize the results reported to the biostatistician for analysis. The biostatistician will perform and report the following analysis. * Number of subjects achieving complete epithelialization at 12 weeks in the Intent to Treat (ITT) population. * Number of subjects achieving complete epithelialization at 12 weeks in the Per Protocol (PP) population.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female ≥ 18 years of age 2. Type 1 or Type 2 Diabetes 3. Grade 2, DFU, non-infected, below the ankle,1.0-12.0 cm2, present ≥ 30 day 4. Ulcer Size 1.0 cm2 to 12.0 cm2 5. Wound location will be distal to the malleolus, excluding between the toes, with no exposed capsule, tendon, or bone, and no tunneling, undermining, or sinus tracts, a depth of ≤ 5mm 6. If more than one non-healing wound is present, the selected ulcer will be the largest and ≥ 1 cm2 in size. 7. At least 2.0 cm between the index wound and other wounds. 8. Study ulcer has been present for at least 30 days and has undergone the 14-day 9. Adequate vascular perfusion of the affected limb, as defined by at least one of the following: Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2, Toe Pressure (TP) ≥ 30 mmHg, Transcutaneous partial pressure of oxygen (TcPO2) ≥ 30 mmHg, or skin perfusion pressure (SPP) ≥ 30 mmHg. 10. WIFI SCORE- wound grade 1, ischemia grade 0-1, and infection grade 0) 11. Screenin
Where
- Corpus Christi, Texas
Collaborators
WCG IRB
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 12, 2025 · Source of record for eligibility and locations