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.
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
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.
Single group
Platelet Rich Plasma
DeviceTropocells(R) Autologous Platelet-Rich Fibrin
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.
Safety- Adverse Events, Serious Adverse Events, Deviations, Violations
The biostatistician will measure and report: 1. Adverse Events (AE), including any untoward or unfavorable medical occurrence in a human study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with a participant's involvement in the research, whether or not considered related to participation in the research, and 2. Serious Adverse Events (SAE), including any adverse event that: i) results in death, ii) is life-threatening, or places the participant at immediate risk of death from the event as it occurred, iii) requires or prolongs hospitalization, iv) causes persistent or significant disability or incapacity,and/o v) results in congenital anomalies or birth defects vi) Is another condition which in the investigator's judge to represent significant hazards, and 3) Unanticipated Problem (UP): Defined by DHHS 45 CFR part 46 as any incident, experience, or outcome that meets the criteria.
Percentage Area Reduction (PAR)
percent wound closure compared to baseline (beginning Active Treatment Phase) to complete wound closure performing assessments every two weeks during the Active Treatment Phase (weeks: 2, 4, 6, 8, 10, and 12).
Time to Wound Closure
Active Phase week (0) will be compared to the week of closure. All weeks will be followed for 2 weekly visits after closure. Closure noted at the last Active Phase visit will be followed for 2 additional weeks to ensure proper documentation of closure.
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Estar Medical dba Medical Technologies, LTD
Lead sponsor
WCG IRB
Collaborator
