Condition: Diabetic Foot Ulcer · Type 1 Diabetes Mellitus · Type 2 Diabetes Mellitus (T2DM) · Sponsor: Estar Medical dba Medical Technologies, LTD
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.
This description comes directly from the study's public registry record.
Marcus L. Gitterle, MD, FACCWS · (830) 643-6166 · marcus.gitterle@woundcentrics.com
Tarek Ibrahim, MBA · (830) 358-7116 · Tarek.Ibrahim@woundcentrics.com
Always discuss trial participation with your own doctor first.
| WoundCentrics Wound Care & Hyperbarics -Corpus Christi - Shoreline | Corpus Christi, Texas, United States | Recruiting |
| Woundcentrics Wound Care Center At Corpus Christi South | Corpus Christi, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06810726