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

NCT ID
NCT05519501
Registry status
Not yet recruiting
Study type
Not specified in the registry data
Phase
Not applicable
Sponsor
Syntr Health Technologies, Inc.

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Enrollment: 62 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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 locations

No study locations are listed in the registry data.

Study details

Start date
September 30, 2026
Primary completion date
September 30, 2027
First posted
August 29, 2022

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT05519501
Registry last updated
August 21, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT05519501 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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