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.
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
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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
Loading…
Loading trial locations…
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