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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05519501

Enrollment

Registered

2022-08-29

Start date

2021-10-10

Completion date

2024-08-09

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer

Keywords

Microsized Fat Tissue, Adipose Tissue, DFU, Wound Management

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.

Interventions

DEVICESyntrFuge System

Microsized Adipose Tissue

PROCEDUREStandard of Care

Offloading

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
Percent of subjects with study wound deemed closed at 12 weeks	12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026