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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