Diabetic Foot UlcerNCT05519501
Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System in the Healing of Diabetic Foot Ulcers
A study testing Syntrfuge Microfragmented Fat in people with Diabetic Foot Ulcer, run by Syntr Health Technologies, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Syntrfuge Microfragmented Fat
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Syntrfuge Microfragmented Fat, Standard of Care
- Keywords
- Microsized Fat Tissue, Adipose Tissue, DFU, Wound Management
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syntrfuge Microfragmented FatDevice
Microsized Adipose Tissue
Standard of CareProcedure or surgery
Debridement and Camboot
| Study group | Role | What they receive |
|---|---|---|
| Syntrfuge Microfragmented Fat | Experimental | Debridement, Microfragmented Adipose Tissue Injectable, Camboot Receives: Device: Syntrfuge Microfragmented Fat |
| Standard of Care | Other | Debridement and Camboot Receives: Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full Wound Healing
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
Measured: 12 weeks
Secondary outcomes (1)
Safety of Intervention measured by number of Adverse and Significantly Adverse Events
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syntr Health Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519501
- Sponsor's protocol ID
- SHT-SYN-01
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System in the Healing of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT05519501
- Acronym / sponsor ID
- SHT-SYN-01
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Microsized Fat Tissue, Adipose Tissue, DFU, Wound Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Syntr Health Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Syntrfuge Microfragmented Fat | Experimental | Device: Syntrfuge Microfragmented FatDebridement, Microfragmented Adipose Tissue Injectable, Camboot |
| Standard of Care | Other | Procedure: Standard of CareDebridement and Camboot |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Syntrfuge Microfragmented FatMicrosized Adipose Tissue | Device | Syntrfuge Microfragmented Fat |
| Standard of CareDebridement and Camboot | Procedure or surgery | Standard of Care |
Primary outcome
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
1 secondary outcome
Safety of Intervention measured by number of Adverse and Significantly Adverse Events
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Syntrfuge Microfragmented Fat in people with Diabetic Foot Ulcer, run by Syntr Health Technologies, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Zobi, EMBA (949-992-5728, info@syntrhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full Wound Healing (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.