Multi-Center, Blinded, Randomized Controlled 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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Syntrfuge Microfragmented Fat

Device

Microsized Adipose Tissue

Standard of care

Procedure

Debridement and Camboot

Primary outcomes

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

Secondary outcomes

Safety of Intervention

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Zobi, EMBA

CONTACT

[email protected]

949-992-5728

Sponsors and collaborators

Lead sponsor

Syntr Health Technologies, Inc.

Industry

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Aug 29, 2022
Registry last updated: Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not yet recruiting