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

Sponsor
Syntr Health Technologies, Inc.
Study ID
NCT05519501
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Syntrfuge Microfragmented Fat — DEVICE
    Microsized Adipose Tissue
  • Standard of Care — PROCEDURE
    Debridement and Camboot

Study Details

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.

Key Dates

First listed
Aug 29, 2022
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Syntrfuge Microfragmented Fat
    Debridement, Microfragmented Adipose Tissue Injectable, Camboot
  • Other: Standard of Care
    Debridement and Camboot

Primary Outcome Measure

Full Wound Healing [ Time Frame: 12 weeks ]

Central Contacts

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