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NCT06810726 · ClinicalTrials.gov registry record · Phase 2
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.
A Phase 2 study of Type 1 Diabetes Mellitus and Diabetic Foot Ulcer, sponsored by Estar Medical dba Medical Technologies.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT06810726: Recruiting Phase 2 study of Type 1 Diabetes Mellitus and Diabetic Foot Ulcer, sponsored by Estar Medical dba Medical Technologies.
NCT06810726 is a Phase 2 study of Type 1 Diabetes Mellitus and Diabetic Foot Ulcer that is actively recruiting participants, run by Estar Medical dba Medical Technologies. The registered enrollment target is 30 participants, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (83% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06810726, a Phase 2 study of Type 1 Diabetes Mellitus and Diabetic Foot Ulcer, is actively recruiting participants, sponsored by Estar Medical dba Medical Technologies.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
* 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
Conditions Studied
Interventions
- DEVICE Platelet Rich Plasma
Study Locations (2)
Texas
- WoundCentrics Wound Care & Hyperbarics -Corpus Christi - Shoreline - Corpus Christi
- Woundcentrics Wound Care Center At Corpus Christi South - Corpus Christi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-04-15 |
| Est. Completion | 2026-08-15 |
| Phase | Phase 2 |
What NCT06810726 shows while recruiting
NCT06810726 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (83% lower).
The record links to 6 conditions, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Platelet Rich Plasma is the first listed.
NCT06810726 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06810726 about?
NCT06810726 is a clinical study titled "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.". 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 ...
What is the current status of trial NCT06810726?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2025-04-15. Estimated completion is 2026-08-15.
What conditions does trial NCT06810726 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus, Diabetic Foot Ulcer, Type 2 Diabetes Mellitus (T2DM), Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer), Chronic Wound Care.
What interventions are being tested in trial NCT06810726?
The interventions under investigation include: Platelet Rich Plasma (DEVICE).
Who is sponsoring clinical trial NCT06810726?
This trial is sponsored by Estar Medical dba Medical Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06810726 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06810726's enrollment target sits among peer trials
30 73rd of 112 higher than 35 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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