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

NCT05519501 | Completed FDA Device

• 1 other identifier: SHT-SYN-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Keywords

Microsized Fat Tissue; Adipose Tissue; DFU; Wound Management

Outcome Measures

Primary Outcomes (1)

• Percent of subjects with study wound deemed closed at 12 weeks

  12 weeks

Study Arms (2)

SyntrFuge System

EXPERIMENTAL

Adipose tissue microsized via the SyntrFuge System

Device: SyntrFuge System

Standard of Care

OTHER

Offloading

Procedure: Standard of Care

Interventions

SyntrFuge System DEVICE

Microsized Adipose Tissue

SyntrFuge System

Standard of Care PROCEDURE

Offloading

Standard of Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have Diabetic Foot Ulcer located at the plantar or dorsal aspect of the foot or the heel with a surface area of 1.0cm2 - 25cm2
• Index ulcer has been present for greater than four weeks
• Diabetics included will be those with HbA1c ≤ 12%
• Subjects aged 18 - 85, inclusive
• The target ulcer has been offloaded for at least 14 days

You may not qualify if:

• Subjects without decisional capacity
• Subjects unable to give informed, written consent
• Subjects with active infection (redness, swelling, pain, suppuration)
• Subjects with active osteomyelitis to the index ulcer
• Subjects with previous treatment with Negative Pressure Wound Therapy, growth factors, radiation, hyperbaric O2, or bioengineered tissue product within 30 days of Screening
• Subjects with a previous diagnosis of HIV or Hep C
• Subject is pregnant or breast feeding
• Subjects receiving oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions
• Subjects under corticosteroid 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

Sponsors & Collaborators

• Syntr Health Technologies, Inc.: lead

Study Sites (1)

Roanoke

Roanoke, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: October 10, 2021
• Primary Completion: August 9, 2024
• Study Completion: August 9, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)