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

  • STATUS
    Recruiting
  • End date
    Dec 17, 2025
  • participants needed
    60
  • sponsor
    Syntr Health Technologies, Inc.
Updated on 7 October 2022
hemoglobin a1c
foot ulcer

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.

Details
Condition Diabetic Foot Ulcer
Treatment Standard of Care, SyntrFuge System
Clinical Study IdentifierNCT05519501
SponsorSyntr Health Technologies, Inc.
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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