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

August 19, 2026 updated by: Syntr Health Technologies, Inc.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24153
        • Roanoke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Subjects who have Diabetic Foot Ulcer located at the pad of the foot or the heel of the foot with a surface area range < 1 sq. cm to 25 sq. cm and < 5 cm in widest diameter on lower extremity, but larger than 1 sq. cm. Diabetics included will be those with HBA1C ≥ 6.5 % and ≤ 12%
  • Subjects with vascular problems absent or resolved (evaluated with Eco Color Doppler and ABI (Ankle Brachial Index, that calculates the ratio of the systolic pressure measured at the ankle and the systolic pressure in the arm, both measured in supine position using wave continue Doppler. If assessable, it has to be greater than/equal to .7) and pressure index finger/arm TBI (Toe Brachial Index, if assessable, it has to be greater than/equal to .6) and/or by the determination of the transcutaneous oxygen pressure (TcPO2 that needs to be equal to or greater than 30 mmHg)) or and alternative biphasic and triphasic waveforms, doppler waveform, or DP+PT
  • Subjects are ambulatory
  • Subjects aged 18 - 85
  • All genders
  • All ethnic backgrounds

Exclusion criteria:

  • Subjects without decisional capacity
  • Subjects unable to give informed, written consent
  • Subjects with active infection (redness, swelling, pain, suppuration)
  • Subjects with osteomyelitis
  • Subjects with a malignancy, burn, collagen vascular disease, sickle cell, vasculopathy, or pyoderma gangrenosum
  • Subjects with active Charcot Arthropathy of the foot
  • Subjects with uncontrolled hyperglycemia (HbA1C > 12 %)
  • Subjects with end stage renal disease, creatinine > 3.0mg/dl within 6 months
  • Subjects with previous Rx with NPWT, growth factors, hyperbaric O2, or bioengineered tissue product within 30 days of enrollment
  • Subject has a > 30% wound Surface area reduction in size at 2 wk after screening
  • Subjects receiving oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions
  • Subjects under steroid 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Syntrfuge Microfragmented Fat
Debridement, Microfragmented Adipose Tissue Injectable, Camboot
Device: Syntrfuge Microfragmented Fat
Microsized Adipose Tissue
Other: Standard of Care
Debridement and Camboot
Procedure: Standard of Care
Debridement and Camboot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Full Wound Healing
Time Frame: 12 weeks
The main study outcome will be time taken to achieve full wound closure, as determined by standard 12-week wound healing milestones defined by PERI and other clinical trials in this space
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Intervention measured by number of Adverse and Significantly Adverse Events
Time Frame: 4 months
Safety of SA (intervention) vs. the control group, as defined by the number of adverse events (all types) reported, the incidence of relapse, pain (assessed using the Visual Analog Scale [VAS] for pain), total time of hospitalization, total time of immobility, and comparisons of quality of life using the Short Form (SF-36) questionnaire.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Syntr Health Technologies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

August 26, 2022

First Posted (Actual)

August 29, 2022

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHT-SYN-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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