Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System in the Healing of Diabetic Foot Ulcers

N/ANot Yet RecruitingNCT05519501

Syntr Health Technologies, Inc.62 enrolled

Overview

This is a randomized controlled multi center study on diabetic patients with the aim of evaluating the efficacy of the adipose tissue processed with the SyntrFuge™ system in diabetic patients with diabetic foot ulcers. In particular, it will be evaluated whether the microsized fat graft will be able to shorten the healing times of these wounds. Patients will be randomized to the treatment group with adipose tissue processed with the SyntrFuge™ system (injection of autologous microsized adipose tissue) or to the control group represented by the standard of care.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetic Foot Ulcer

Interventions

Syntrfuge Microfragmented Fat

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion criteria: * Subjects who have Diabetic Foot Ulcer located at the pad of the foot or the heel of the foot with a surface area range \< 1 sq. cm to 25 sq. cm and \< 5 cm in widest diameter on lower extremity, but larger than 1 sq. cm. Diabetics included will be those with HBA1C ≥ 6.5 % and ≤ 12% * Subjects with vascular problems absent or resolved (evaluated with Eco Color Doppler and ABI (Ankle Brachial Index, that calculates the ratio of the systolic pressure measured at the ankle and the systolic pressure in the arm, both measured in supine position using wave continue Doppler. If assessable, it has to be greater than/equal to .7) and pressure index finger/arm TBI (Toe Brachial Index, if assessable, it has to be greater than/equal to .6) and/or by the determination of the transcutaneous oxygen pressure (TcPO2 that needs to be equal to or greater than 30 mmHg)) or and alternative biphasic and triphasic waveforms, doppler waveform, or DP+PT * Subjects are ambulatory * Subjects aged 18 - 85 * All genders * All ethnic backgrounds Exclusion criteria: * Subjects without decisional capacity * Subjects unable to give informed, written consent * Subjects with active infection (redness, swelling, pain, suppuration) * Subjects with osteomyelitis * Subjects with a malignancy, burn, collagen vascular disease, sickle cell, vasculopathy, or pyoderma gangrenosum * Subjects with active Charcot Arthropathy of the foot * Subjects with uncontrolled hyperglycemia (HbA1C \> 12 %) * Subjects with end stage renal disease, creatinine \> 3.0mg/dl within 6 months * Subjects with previous Rx with NPWT, growth factors, hyperbaric O2, or bioengineered tissue product within 30 days of enrollment * Subject has a \> 30% wound Surface area reduction in size at 2 wk after screening * Subjects receiving oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions * Subjects under steroid therapy, unless taking dose of 5mg/dl or less * Subjects with any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study

Outcomes

Primary Outcomes

Full Wound Healing

The main study outcome will be time taken to achieve full wound closure, as determined by standard 12-week wound healing milestones defined by PERI and other clinical trials in this space

Time frame: 12 weeks

Secondary Outcomes

Safety of Intervention measured by number of Adverse and Significantly Adverse Events

Safety of SA (intervention) vs. the control group, as defined by the number of adverse events (all types) reported, the incidence of relapse, pain (assessed using the Visual Analog Scale \[VAS\] for pain), total time of hospitalization, total time of immobility, and comparisons of quality of life using the Short Form (SF-36) questionnaire.

Time frame: 4 months