Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers

Phase 3

Not yet recruiting

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: ADRCs; Other: standard care; Other: Placebo

• Registration Number: NCT05095389
• Lead Sponsor: Paracrine, INC.

Brief 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).

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-10-27
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-28
• Study Start: 2023-02-28
• Primary Completion: 2024-12
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

• T1D or T2D
• Diabetic Foot Ulcer, from 1 to 12 months in duration
• Wagner Grade 1 or Superficial 2
• Adequate perfusion
• Able to undergo liposuction

Exclusion Criteria

• Diabetic Foot Ulcer penetrates to capsule, tendon, or bone
• Active infection
• Non-diabetic neuropathy
• Significant cardiovascular event within 6 months before screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care plus ARDCs	standard care	* All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure. * All patients will receive standard care for their Diabetic Foot Ulcer. * Additionally, patients randomized to the ADRC arm will receive ADRCs
Standard Care plus Placebo	standard care	* All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure. * All patients will receive standard care for their Diabetic Foot Ulcer. * Additionally, patients randomized to the Control arm will receive Placebo
Standard Care plus ARDCs	ADRCs	* All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure. * All patients will receive standard care for their Diabetic Foot Ulcer. * Additionally, patients randomized to the ADRC arm will receive ADRCs
Standard Care plus Placebo	Placebo	* All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure. * All patients will receive standard care for their Diabetic Foot Ulcer. * Additionally, patients randomized to the Control arm will receive Placebo

Primary Outcome Measures

Name	Time	Method
DFU Closure Rate	12 Weeks	The rate of closure at 12 Weeks

Secondary Outcome Measures

Name	Time	Method
Percent Reduction of Wound Area	12 Weeks	Percent Reduction of Wound Area from Baseline to 12 Weeks for Ulcers not Completely Healed