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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: SyntrFuge System
* Procedure: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SyntrFuge System<br>Adipose tissue microsized via the SyntrFuge System | Device: SyntrFuge System<br>* Microsized Adipose Tissue<br>|
| Other: Standard of Care<br>Offloading | Procedure: Standard of Care<br>* Offloading<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects with study wound deemed closed at 12 weeks |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DFU, Microsized Fat Tissue, Adipose Tissue, Wound Management