Multi-Center, Randomized Controlled Clinical Investigation Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System in the Healing of Diabetic Foot Ulcers

Syntr Health Technologies, Inc.1 site in 1 country60 target enrollmentOctober 10, 2021

ConditionsDiabetic Foot Ulcer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Diabetic Foot Ulcer
Sponsor: Syntr Health Technologies, Inc.
Enrollment: 60
Locations: 1
Primary Endpoint: Percent of subjects with study wound deemed closed at 12 weeks
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 10, 2021

End Date

December 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Syntr Health Technologies, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who have Diabetic Foot Ulcer located at the plantar or dorsal aspect of the foot or the heel with a surface area of 1.0cm2 - 25cm2
•Index ulcer has been present for greater than four weeks
•Diabetics included will be those with HbA1c ≤ 12%
•Subjects aged 18 - 85, inclusive
•The target ulcer has been offloaded for at least 14 days

Exclusion Criteria

•Subjects without decisional capacity
•Subjects unable to give informed, written consent
•Subjects with active infection (redness, swelling, pain, suppuration)
•Subjects with active osteomyelitis to the index ulcer
•Subjects with previous treatment with Negative Pressure Wound Therapy, growth factors, radiation, hyperbaric O2, or bioengineered tissue product within 30 days of Screening
•Subjects with a previous diagnosis of HIV or Hep C
•Subject is pregnant or breast feeding
•Subjects receiving oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions
•Subjects under corticosteroid 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