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New treatment option for Diabetic Foot Ulcer
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.
ClinicalTrials.gov ID: NCT06810726
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
- Wound location will be distal to the malleolus, excluding between the toes, with no exposed capsule, tendon, or bone, and no tunneling, undermining...
You likely can't join if
- 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.
- Documented sepsis, proven with blood cultures, within 2 weeks of the trial or during the Screening Phase.
- Soft tissue infection at the designated ulcer or the same extremity within 2 weeks of the time of screening.
See the full eligibility criteria
Who can join
- 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
- Wound location will be distal to the malleolus, excluding between the toes, with no exposed capsule, tendon, or bone, and no tunneling, undermining, or sinus tracts, a depth of ≤ 5mm
- If more than one non-healing wound is present, the selected ulcer will be the largest and ≥ 1 cm2 in size.
- At least 2.0 cm between the index wound and other wounds.
- Study ulcer has been present for at least 30 days and has undergone the 14-day
- Adequate vascular perfusion of the affected limb, as defined by at least one of the following: Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2, Toe Pressure (TP) ≥ 30 mmHg, Transcutaneous partial pressure of oxygen (TcPO2)...
- WIFI SCORE- wound grade 1, ischemia grade 0-1, and infection grade 0)
- Screening Period of the standard of care with 20% or less wound closure.
- No Clinical Signs of Infection at the wound site or the affected limb.
- Post-debridement without signs of necrotic tissue.
- Normal Platelet count ≥ 105,000 and \<450, 000 (according to CBC)
- Hemoglobin (Hgb) ≥10 g/dL and Hematocrit (HCT) ≥ 27% (according to CBC)
- Controlled glucose level HbA1C ≤ 12%, with active treatment being conducted to reduce the value to by a primary provider or endocrinologist
- No Chronic Renal Failure (CRF); Estimated glomerular filtration rate (eGFR) ≥ 15
- PT/PTT - INR between 2.0-3.0 (with blood thinners).
- Nutritional Status with no severe protein deficiency, Pre-albumen \>15 mg/dL
- Demonstrated adequate offloading using DH Walker boot with Plastazote Insole (OR equivalent off-loading device).
- If a female of childbearing potential, must have a negative serum or urine pregnancy test at screening and use contraception or abstinence during trial.
- Male people agree to use contraception or abstinence during the trial.
- The subject has provided written informed consent before any screening procedures and agrees to comply with study procedures and requirements.
What rules you out
- 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.
- Documented sepsis, proven with blood cultures, within 2 weeks of the trial or during the Screening Phase.
- Soft tissue infection at the designated ulcer or the same extremity within 2 weeks of the time of screening.
- Osteomyelitis at the designated wound site; using ESR ≥ and /or CRP ≥ 7.9 mg/d as a screen.
- CKD Level G5: Chronic Renal Failure (CRF) sufficient to require dialysis.
- Religious constraints to using blood products, including autologous blood.
- Alcohol or substance abuse (other than tobacco) within 2 months before enrollment.
- Blood-borne or communicable diseases that would likely prevent full participation in the trial (e.g., HIV, AIDs, COVID, TB).
- Participation in another clinical trial involving a device or a systematically administered investigational study drug or treatment within 30 days of initiating the trial.
- The subject has severe lymphedema (Stage 3) where the individual cannot lift the extremity on their own secondary to the amount of edema and fluid weight.
- The subject is undergoing hemodialysis.
- people who are cognitively impaired, unable to understand the informed consent, or have a health care proxy.
- people with sickle cell anemia, thrombocytopenia, leukemia, or blood dyscrasia.
- History of problems with coagulation, abnormal thrombocytes (platelets), or receiving heparin intravenously; people taking coumadin, aspirin, clopidogrel, or other oral anti-coagulants are not excluded.
- Anemia where weekly blood draws of 12 or 23 per week may not be tolerated.
- Received electrostimulation, hyperbaric treatments, growth factors, or any cell or tissue-derived therapy for any wounds 30 days before entry into the study.
- Systemic corticosteroids, (except for people receiving inhaled corticosteroid treatments for asthma or COPD) 30 days before entry into the study.
- Received within 30 days before the study or scheduled to receive medications or treatments known to interfere with or affect the rate or quality of wound closure (e.g., systemic steroids, immunosuppressive therapy...
- Received radiation therapy or chemotherapy within the previous 3 months.
- people with known sensitivity to blood components such as those in the PRF kit.
- The subject has inadequate venous access for repeated blood draws required for the PRP preparation.
The study team makes the final eligibility decision.
Where it's taking place
- Corpus Christi, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Corpus Christi, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.