NCT05095389

Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers

Adipose Derived Regenerative Cells (ADRCs) in the Treatment of Diabetic Foot Ulcers: a Prospective, Double-blind, Multi-center, Randomized, Parallel-group Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: Paracrine, INC. · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Prospective, Double-blind, Multi-center, Randomized, Parallel-group safety and efficacy study of adipose-derived regenerative cells (ADRCs) in the treatment of patients with diabetic foot ulcers (DFU).

Detailed description

Subjects will have at least one diabetic foot ulcer between 1 cm2 and 16 cm2 area that remains open despite at least 30 days of DFU care and will need debridement as a part of their care. Subjects will be randomly assigned to one of two groups (ADRC Group will receive standard care plus ADRC, and Control Group will receive standard care plus matched placebo). ADRCs will be harvested from a small volume liposuction performed on the same day as, but prior to, the debridement procedure. Fat harvest will occur through small volume (approximately 100-200 mL) liposuction prior to the surgical debridement procedure on the same day as the planned autograft procedure. The lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs for application to an autograft site. Cells will be delivered via direct injection (minimal wound penetration with a 22 gauge needle, total volume 5 mL) into the DFU (injected around the circumference and applied to the base of the ulcer).

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	ADRCs	Administration of Autologous Adipose Derived Regenerative Cells into the Diabetic Foot Ulcer
OTHER	standard care	standard care
OTHER	Placebo	placebo

Timeline

• Start date: 2023-02-28
• Primary completion: 2024-12-01
• Completion: 2025-07-01
• First posted: 2021-10-27
• Last updated: 2022-09-28

Regulatory

• FDA-regulated device study