Recruiting

Tropocells Autologous PRF for Chronic Diabetic Foot Ulcers

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Platelet Rich Plasma

Device
Who is being recruted

Autoimmune Diseases+18

+ Cardiovascular Diseases

+ Diabetes Mellitus

From 18 to 80 Years
+47 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorEstar Medical dba Medical Technologies, LTD
Study ContactMarcus L. Gitterle, MD, FACCWSMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 15, 2025

Actual date on which the first participant was enrolled.

This clinical trial focuses on evaluating a treatment for people with chronic diabetic foot ulcers, a common problem for those with diabetes. The study uses a special gel called Tropocells Autologous PRF, which is made from the patient's own blood, to help heal these wounds. By testing this new approach, the study aims to see if this treatment can effectively close these stubborn ulcers and improve healing overall, addressing a significant issue for many diabetic patients who struggle with foot wounds that do not heal properly. Participants in the study first enter a two-week period where they receive regular care, including wound cleaning and special dressings. If their wounds do not improve by at least 20%, they move on to the 12-week treatment phase. During this phase, they receive the Tropocells gel on their wounds weekly, in addition to standard care. The study measures how well the wounds heal, looking for complete closure and checking for any side effects. Participants with fully healed wounds are then monitored for a few more months to ensure the wounds stay closed. This research helps understand the safety and effectiveness of the treatment in promoting wound healing.

Official TitleEVALUATION 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)
NCT06810726
Principal SponsorEstar Medical dba Medical Technologies, LTD
Study ContactMarcus L. Gitterle, MD, FACCWSMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesCardiovascular DiseasesDiabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic AngiopathiesDiabetic NeuropathiesEndocrine System DiseasesFoot DiseasesImmune System DiseasesLeg UlcerMetabolic DiseasesNutritional and Metabolic DiseasesSkin DiseasesSkin UlcerVascular DiseasesFoot UlcerSkin and Connective Tissue DiseasesDiabetic FootGlucose Metabolism DisordersDiabetes Complications

Criteria

23 inclusion criteria required to participate
Male or female ≥ 18 years of age
Type 1 or Type 2 Diabetes
Grade 2, DFU, non-infected, below the ankle,1.0-12.0 cm2, present ≥ 30 day
Ulcer Size 1.0 cm2 to 12.0 cm2
Show More Criteria
24 exclusion criteria prevent from participating
Life expectancy is less than 12 months.
Anemia Hgb ≤ 10 g/dL and HCT ≤ 27%.
Ulcers of other than diabetic foot pathophysiology.
Participation in another clinical trial involving a device or a systematically administered investigational study drug or treatment within 30 days.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
During Screen-the participant will be treated with standard of care (SOC) for 2 weeks, including education, nutritional supplement, weekly wound assessments and care with off-loading. After the two weekly visits, subjects who meet the inclusion/exclusion criterion, show adequate perfusion and area reduction less than 20%, and comply with the standard of care will be enrolled in the Active Treatment Phase. During the Active Treatment Phase, subjects will be treated weekly with TropoCells® Autologous Platelet-rich Fibrin (PRF) for twelve (12) weeks and continued SOC. Wound area will be documented with measures and photographs before and after cleansing and debridement (as needed). Clean wounds treated topically with active therapy will be covered with a non-adherent layered absorbent foam dressing with an external protective third layer. Mild compression will be applied with continued off-loading at least 2 week after closure. Follow-up evaluation after closure at 1 and 3 months.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

WoundCentrics Wound Care & Hyperbarics -Corpus Christi - Shoreline

Corpus Christi, United StatesOpen WoundCentrics Wound Care & Hyperbarics -Corpus Christi - Shoreline in Google Maps
Recruiting

Woundcentrics Wound Care Center At Corpus Christi South

Corpus Christi, United States
Recruiting
2 Study Centers