Diabetic Foot Ulcer
Conditions
Keywords
Microsized Fat Tissue, Adipose Tissue, DFU, Wound Management
Brief 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.
Interventions
DEVICESyntrfuge Microfragmented Fat
Microsized Adipose Tissue
PROCEDUREStandard of Care
Debridement and Camboot
Sponsors
Syntr Health Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Full Wound Healing | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety of Intervention measured by number of Adverse and Significantly Adverse Events | 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. |
Contacts
CONTACTAhmed Zobi, EMBA
Outcome results
None listed