Actively Recruiting
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.
Led by Estar Medical dba Medical Technologies, LTD · Updated on 2025-06-12
30
Participants Needed
2
Research Sites
69 weeks
Total Duration
On this page
Sponsors
E
Estar Medical dba Medical Technologies, LTD
Lead Sponsor
W
WCG IRB
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older
- Diagnosed with Type 1 or Type 2 Diabetes
- Diabetic foot ulcer Grade 2, non-infected, below the ankle, sized 1.0 to 12.0 cm2, present for at least 30 days
- Wound depth 5mm or less with no exposed capsule, tendon, or bone and no tunneling or undermining
- If multiple wounds, the largest ulcer of at least 1 cm2 is selected
- At least 2.0 cm distance between selected wound and any other wounds
- Adequate blood flow to affected limb based on specific tests (ABI, Toe Pressure, TcPO2, or SPP)
- Wound Infection Foot Infection (WIFI) score indicating low grade infection and ischemia
- Standard care run-in period with 20% or less wound closure
- No clinical signs of infection or necrotic tissue after debridement
- Normal platelet count and adequate hemoglobin and hematocrit levels
- Controlled blood glucose levels (HbA1C ≤ 12%) with active management
- No chronic renal failure; adequate kidney function (eGFR ≥ 15)
- Blood clotting parameters within specified range (PT/PTT-INR 2.0-3.0)
- No severe protein deficiency (pre-albumin > 15 mg/dL)
- Use of approved off-loading device such as a DH Walker boot with a Plastazote insole
- Women of childbearing potential must have a negative pregnancy test and use contraception or abstinence
- Male subjects must agree to use contraception or abstinence
- Provided informed consent and agree to study procedures
You will not qualify if you...
- Life expectancy less than 12 months
- Anemia with hemoglobin ≤ 10 g/dL and hematocrit ≤ 27%
- Ulcers not caused by diabetic foot disease
- Participation in another device or drug clinical trial within 30 days
- Sepsis or soft tissue infection at wound site or same limb within 2 weeks before screening
- Osteomyelitis at the wound site indicated by elevated ESR or CRP
- Severe chronic kidney failure requiring dialysis
- Religious objections to blood products including autologous blood
- Alcohol or substance abuse within 2 months prior to enrollment
- Blood-borne or communicable diseases that would prevent participation
- Severe lymphedema preventing limb lifting
- Undergoing hemodialysis
- Cognitive impairment or inability to consent
- Blood disorders such as sickle cell anemia, thrombocytopenia, leukemia
- History of coagulation problems or intravenous heparin use
- Anemia intolerant to frequent blood draws
- Recent electrostimulation, hyperbaric, growth factors, cell or tissue therapies within 30 days
- Recent systemic corticosteroids (except inhaled for asthma or COPD) within 30 days
- Recent treatments affecting wound healing like immunosuppressants, dialysis, radiation within specified timeframes
- Sensitivity to blood components in the PRF kit
- Inadequate venous access for blood draws needed for treatment preparation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
WoundCentrics Wound Care & Hyperbarics -Corpus Christi - Shoreline
Corpus Christi, Texas, United States, 78404
Actively Recruiting
2
Woundcentrics Wound Care Center At Corpus Christi South
Corpus Christi, Texas, United States, 78414
Actively Recruiting
Research Team
M
Marcus L. Gitterle, MD, FACCWS
CONTACT
T
Tarek Ibrahim, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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