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Not yet recruitingNCT05519501Updated Aug 21, 2026

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

An interventional study of Syntrfuge Microfragmented Fat and Standard of Care in Diabetic Foot Ulcer, sponsored by Syntr Health Technologies, Inc.. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Syntr Health Technologies, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetic Foot Ulcer

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Keywords

  • Microsized Fat Tissue
  • Adipose Tissue
  • DFU
  • Wound Management
03

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's planned enrollment of 62 is close to the median of 60 across 826 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

Syntr Health Technologies, Inc. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    Syntrfuge Microfragmented Fat

    Debridement, Microfragmented Adipose Tissue Injectable, Camboot

    Device: Syntrfuge Microfragmented Fat

  • Other
    Standard of Care

    Debridement and Camboot

    Procedure: Standard of Care

Interventions

  • DeviceSyntrfuge Microfragmented Fat

    Microsized Adipose Tissue

  • ProcedureStandard of Care

    Debridement and Camboot

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: 4 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05519501
Lead sponsor
Syntr Health Technologies, Inc.
Responsible party
Sponsor
First posted
Aug 29, 2022
Start date
Sep 30, 2026 (estimated)
Primary completion
Sep 30, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Aug 21, 2026

Study contacts

Ahmed Zobi, EMBA
Contact
info@syntrhealth.com
949-992-5728

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Syntr Health Technologies, Inc.

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