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.

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Conditions

Diabetic Foot UlcerType 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)Neuroischemic Foot UlcerChronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)Chronic Wound CarePRF used for Wagner Grade 2 DFUTropocells Platelet-rich FibrinPlatelet-rich Plasma (PRP)Platelet-derived Factors for wound care

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

EVALUATION 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)

Quick Facts

Study Start:2025-04-15
Study Completion:2026-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06810726

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female ≥ 18 years of age
  2. 2. Type 1 or Type 2 Diabetes
  3. 3. Grade 2, DFU, non-infected, below the ankle,1.0-12.0 cm2, present ≥ 30 day
  4. 4. Ulcer Size 1.0 cm2 to 12.0 cm2
  5. 5. 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
  6. 6. If more than one non-healing wound is present, the selected ulcer will be the largest and ≥ 1 cm2 in size.
  7. 7. At least 2.0 cm between the index wound and other wounds.
  8. 8. Study ulcer has been present for at least 30 days and has undergone the 14-day
  9. 9. 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) ≥ 30 mmHg, or skin perfusion pressure (SPP) ≥ 30 mmHg.
  10. 10. WIFI SCORE- wound grade 1, ischemia grade 0-1, and infection grade 0)
  11. 11. Screening Period of the standard of care with 20% or less wound closure.
  12. 12. No Clinical Signs of Infection at the wound site or the affected limb.
  13. 13. Post-debridement without signs of necrotic tissue.
  14. 14. Normal Platelet count ≥ 105,000 and \<450, 000 (according to CBC)
  15. 15. Hemoglobin (Hgb) ≥10 g/dL and Hematocrit (HCT) ≥ 27% (according to CBC)
  16. 16. Controlled glucose level HbA1C ≤ 12%, with active treatment being conducted to reduce the value to by a primary provider or endocrinologist
  17. 17. No Chronic Renal Failure (CRF); Estimated glomerular filtration rate (eGFR) ≥ 15
  18. 18. PT/PTT - INR between 2.0-3.0 (with blood thinners).
  19. 19. Nutritional Status with no severe protein deficiency, Pre-albumen \>15 mg/dL
  20. 20. Demonstrated adequate offloading using DH Walker boot with Plastazote Insole (OR equivalent off-loading device).
  21. 21. If a female of childbearing potential, must have a negative serum or urine pregnancy test at screening and use contraception or abstinence during trial.
  22. 22. Male subjects agree to use contraception or abstinence during the trial.
  23. 23. The subject has provided written informed consent before any screening procedures and agrees to comply with study procedures and requirements.
  1. 1. Life expectancy is less than 12 months.
  2. 2. Anemia Hgb ≤ 10 g/dL and HCT ≤ 27%.
  3. 3. Ulcers of other than diabetic foot pathophysiology.
  4. 4. Participation in another clinical trial involving a device or a systematically administered investigational study drug or treatment within 30 days.
  5. 5. Documented sepsis, proven with blood cultures, within 2 weeks of the trial or during the Screening Phase.
  6. 6. Soft tissue infection at the designated ulcer or the same extremity within 2 weeks of the time of screening.
  7. 7. Osteomyelitis at the designated wound site; using ESR ≥ and /or CRP ≥ 7.9 mg/d as a screen.
  8. 8. CKD Level G5: Chronic Renal Failure (CRF) sufficient to require dialysis.
  9. 9. Religious constraints to using blood products, including autologous blood.
  10. 10. Alcohol or substance abuse (other than tobacco) within 2 months before enrollment.
  11. 11. Blood-borne or communicable diseases that would likely prevent full participation in the trial (e.g., HIV, AIDs, COVID, TB).
  12. 12. Participation in another clinical trial involving a device or a systematically administered investigational study drug or treatment within 30 days of initiating the trial.
  13. 13. 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.
  14. 14. The subject is undergoing hemodialysis.
  15. 15. Subjects who are cognitively impaired, unable to understand the informed consent, or have a health care proxy.
  16. 16. Subjects with sickle cell anemia, thrombocytopenia, leukemia, or blood dyscrasia.
  17. 17. History of problems with coagulation, abnormal thrombocytes (platelets), or receiving heparin intravenously; subjects taking coumadin, aspirin, clopidogrel, or other oral anti-coagulants are not excluded.
  18. 18. Anemia where weekly blood draws of 12 or 23 per week may not be tolerated.
  19. 19. Received electrostimulation, hyperbaric treatments, growth factors, or any cell or tissue-derived therapy for any wounds 30 days before entry into the study.
  20. 20. Systemic corticosteroids, (except for subjects receiving inhaled corticosteroid treatments for asthma or COPD) 30 days before entry into the study.
  21. 21. 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, autoimmune disease therapy within the past 12 months, dialysis, radiation therapy to the treatment area, vascular surgery, angioplasty, or thrombolysis.
  22. 22. Received radiation therapy or chemotherapy within the previous 3 months.
  23. 23. Subjects with known sensitivity to blood components such as those in the PRF kit.
  24. 24. The subject has inadequate venous access for repeated blood draws required for the PRP preparation.

Contacts and Locations

Study Contact

Marcus L. Gitterle, MD, FACCWS
CONTACT
(830) 643-6166
marcus.gitterle@woundcentrics.com
Tarek Ibrahim, MBA
CONTACT
(830) 358-7116
Tarek.Ibrahim@woundcentrics.com

Principal Investigator

Adrianne P Smith, MD
STUDY_DIRECTOR
Sanogenix Medical, LLC
Marcus L. Gitterle, MD
PRINCIPAL_INVESTIGATOR
WoundCentrics

Study Locations (Sites)

WoundCentrics Wound Care & Hyperbarics -Corpus Christi - Shoreline
Corpus Christi, Texas, 78404
United States
Woundcentrics Wound Care Center At Corpus Christi South
Corpus Christi, Texas, 78414
United States

Collaborators and Investigators

Sponsor: Estar Medical dba Medical Technologies, LTD

  • Adrianne P Smith, MD, STUDY_DIRECTOR, Sanogenix Medical, LLC
  • Marcus L. Gitterle, MD, PRINCIPAL_INVESTIGATOR, WoundCentrics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-15
Study Completion Date2026-08-15

Study Record Updates

Study Start Date2025-04-15
Study Completion Date2026-08-15

Terms related to this study

Keywords Provided by Researchers

  • PRF used for Wagner Grade 2 DFU
  • Tropocells Platelet-rich Fibrin
  • Platelet-rich Plasma (PRP)
  • Platelet-derived Factors for wound care
  • Chronic Wound Care

Additional Relevant MeSH Terms

  • 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