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.

Recruiting Phase 2 Interventional Study
Diabetic Foot Ulcer Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus (T2DM) Neuroischemic Foot Ulcer Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer) Chronic Wound Care
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Estar Medical dba Medical Technologies, LTD · Industry
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About This Trial
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 \[is/are\]: Meas…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 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…
Contacts

Marcus L. Gitterle, MD, FACCWS

(830) 643-6166

marcus.gitterle@woundcentrics.com

CONTACT

Tarek Ibrahim, MBA

(830) 358-7116

Tarek.Ibrahim@woundcentrics.com

CONTACT