NCT05519501

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Syntr Health Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	SyntrFuge System	Microsized Adipose Tissue
PROCEDURE	Standard of Care	Offloading

Timeline

• Start date: 2021-10-10
• Primary completion: 2024-08-09
• Completion: 2024-08-09
• First posted: 2022-08-29
• Last updated: 2024-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study