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

Status: Completed

Conditions: Diabetic Foot Ulcer

Treatments: Device: SyntrFuge System; Procedure: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT05519501

SHT-SYN-01

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. Index ulcer has been present for greater than four weeks
3. Diabetics included will be those with HbA1c ≤ 12%
4. Subjects aged 18 - 85, inclusive
5. The target ulcer has been offloaded for at least 14 days

Exclusion criteria

1. Subjects without decisional capacity
2. Subjects unable to give informed, written consent
3. Subjects with active infection (redness, swelling, pain, suppuration)
4. Subjects with active osteomyelitis to the index ulcer
5. Subjects with previous treatment with Negative Pressure Wound Therapy, growth factors, radiation, hyperbaric O2, or bioengineered tissue product within 30 days of Screening
6. Subjects with a previous diagnosis of HIV or Hep C
7. Subject is pregnant or breast feeding
8. Subjects receiving oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions
9. Subjects under corticosteroid therapy, unless taking dose of 5mg/dl or less
10. Subjects with any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

SyntrFuge System

Experimental group

Description:

Adipose tissue microsized via the SyntrFuge System

Treatment:

Device: SyntrFuge System

Standard of Care

Other group

Description:

Offloading

Treatment:

Procedure: Standard of Care