Study of Tropocells(R) for Diabetic Foot Ulcers
This study is testing a treatment called Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for people with diabetic foot ulcers (wounds on the foot due to diabetes). Tropocells(R) PRF uses your own blood to create a gel that may help wounds heal. You might be able to join if you are 18-80 years old, have Type 1 or Type 2 diabetes, and have a specific type of non-infected diabetic foot ulcer that is between 1.0 and 12.0 square centimeters in size and has been present for at least 30 days. The main goal is to see if Tropocells(R) PRF can help these wounds close completely within 12 weeks. Researchers plan to enroll about 30 people.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It will involve approximately 30 participants and does not have a comparison group.
- What's involved
- You would first have a 2-week run-in phase with weekly clinic visits for standard wound care. If your wound doesn't improve enough, you would then enter a 12-week active treatment phase with weekly clinic visits for Tropocells(R) PRF application and standard care.
- Compensation
- Not stated in the trial record.
- Follow-up
- If your wound closes completely, you will be followed for 1 month and then again at 3 months after closure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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.
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Adrianne P Smith, MD · STUDY_DIRECTOR · Sanogenix Medical, LLC
- Marcus L. Gitterle, MD · PRINCIPAL_INVESTIGATOR · WoundCentrics
Who to contact
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What this trial measures
- Complete wound closure12 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.