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.

NCT06810726 | Recruiting Phase 2 DMC FDA Device

• 1 other identifier: RND054-Tropocells PRF for DFU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Complete wound closure

  * An independent validation will be performed by an independent wound care specialist who will determine if the wound is fully closed, demonstrating 100% re-epithelialization persisting for two (2) subsequent weekly assessments. The validation will be reviewed with the treating researcher and the PI to formalize the results reported to the biostatistician for analysis. The biostatistician will perform and report the following analysis. * Number of subjects achieving complete epithelialization at 12 weeks in the Intent to Treat (ITT) population. * Number of subjects achieving complete epithelialization at 12 weeks in the Per Protocol (PP) population.

  12 weeks of active therapy weekly applications

Secondary Outcomes (1)

• Safety- Adverse Events, Serious Adverse Events, Deviations, Violations

  Screening Phase- 2 weeks and Active Treatment Phase- 12 weeks

Other Outcomes (2)

• Percentage Area Reduction (PAR)

  12 weeks

• Time to Wound Closure

  12 weeks

Study Arms (1)

T1DM,T2DM participants with non-infected, neuroischemic, chronic foot ulcers

EXPERIMENTAL

During Screen-the participant will be treated with standard of care (SOC) for 2 weeks, including education, nutritional supplement, weekly wound assessments and care with off-loading. After the two weekly visits, subjects who meet the inclusion/exclusion criterion, show adequate perfusion and area reduction less than 20%, and comply with the standard of care will be enrolled in the Active Treatment Phase. During the Active Treatment Phase, subjects will be treated weekly with TropoCells® Autologous Platelet-rich Fibrin (PRF) for twelve (12) weeks and continued SOC. Wound area will be documented with measures and photographs before and after cleansing and debridement (as needed). Clean wounds treated topically with active therapy will be covered with a non-adherent layered absorbent foam dressing with an external protective third layer. Mild compression will be applied with continued off-loading at least 2 week after closure. Follow-up evaluation after closure at 1 and 3 months.

Device: Platelet Rich Plasma

Interventions

Platelet Rich Plasma DEVICE

Tropocells(R) Autologous Platelet-Rich Fibrin

T1DM,T2DM participants with non-infected, neuroischemic, chronic foot ulcers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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, 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) ≥ 30 mmHg, or skin perfusion pressure (SPP) ≥ 30 mmHg.
• 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)

You may not qualify 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.
• 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.
• Subjects who are cognitively impaired, unable to understand the informed consent, or have a health care proxy.

Sponsors & Collaborators

• Estar Medical dba Medical Technologies, LTD: lead
• WCG IRB: collaborator

Study Sites (2)

WoundCentrics Wound Care & Hyperbarics -Corpus Christi - Shoreline

Corpus Christi, Texas, 78404, United States

RECRUITING

Woundcentrics Wound Care Center At Corpus Christi South

Corpus Christi, Texas, 78414, United States

RECRUITING

Related Publications (2)

• Piccin A, Di Pierro AM, Canzian L, Primerano M, Corvetta D, Negri G, Mazzoleni G, Gastl G, Steurer M, Gentilini I, Eisendle K, Fontanella F. Platelet gel: a new therapeutic tool with great potential. Blood Transfus. 2017 Jul;15(4):333-340. doi: 10.2450/2016.0038-16. Epub 2016 Jul 25.

  PMID: 27483482 BACKGROUND

• Chen P, Vilorio NC, Dhatariya K, Jeffcoate W, Lobmann R, McIntosh C, Piaggesi A, Steinberg J, Vas P, Viswanathan V, Wu S, Game F. Guidelines on interventions to enhance healing of foot ulcers in people with diabetes (IWGDF 2023 update). Diabetes Metab Res Rev. 2024 Mar;40(3):e3644. doi: 10.1002/dmrr.3644. Epub 2023 May 25.

  PMID: 37232034 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Leg Ulcer; Foot Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Foot Diseases

Study Officials

• Adrianne P Smith, MD

  Sanogenix Medical, LLC

  STUDY DIRECTOR

• Marcus L. Gitterle, MD

  WoundCentrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcus L. Gitterle, MD, FACCWS

CONTACT

(830) 643-6166; marcus.gitterle@woundcentrics.com

Tarek Ibrahim, MBA

CONTACT

(830) 358-7116; Tarek.Ibrahim@woundcentrics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Validation Process- upon completion of treatment the cases will be evaluated by 3rd party validator who will review the photographs to determine if complete wound closure has occurred.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: TROPOCELLS(R) Autologous Platelet-Rich Plasma (PRF) Prospective, open-label, non-randomized, single-arm, single-agent Tropocells(R) Platelet-rich fibrin (PRF) device used to render PRF therapy applied weekly, with the primary endpoint complete (100%) wound closure response to a 12-week treatment period, where closed wounds will undergo an adjudicated assessment.

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 6, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Anticipated 510K submission- Jul2026 Duration while 510K is under consideration- 90 days
• Access Criteria: The clinical research organization, Global Clinical Research Institute-GCRI), and biostatistician (Strategic Solutions, Inc.), regulatory consultant, Biologics Consulting Group-BCG,and the WCG IRB will be able to access the data in deidentified format and potentially as individual patient data (IPD) during trial conduct or in preparation for the 510K submission. If the FDA clears the device, we may publish the results to share with the medical community; however, only deidentified case studies and/or analyzed data will be used. IPD may also be shared with other researchers in a registry once the device has been cleared.

Locations

US (2)