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Can your own fat help heal diabetic wounds?

NCT ID NCT05519501

Disease control Sponsor: Syntr Health Technologies, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether injecting a person's own fat tissue, processed with the SyntrFuge system, can help diabetic foot ulcers heal faster. About 62 people with diabetic foot ulcers will be randomly assigned to receive either the fat graft or standard wound care. The main goal is to see if the fat graft shortens the time to complete wound closure within 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Autologous microfragmented adipose tissue (fat) processed with the SyntrFuge system, injected into the wound
What this could lead to
If effective, this approach could offer a new way to help diabetic foot ulcers close faster, potentially reducing complications and amputations.
What could go wrong
This is a small, early-stage trial, and the fat graft may not heal wounds faster than standard care. There are also risks of infection or pain at the injection site.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 62 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Diabetic Foot

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic foot ulcer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

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