Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers (ASCEND)

Paracrine

Status and phase: Not yet enrolling; Phase 3

Conditions: Diabetic Foot Ulcer

Treatments: Other: Placebo; Other: standard care; Device: ADRCs

Study type: Interventional

Funder types: Industry

Identifiers

NCT05095389

2021-01

Details and patient eligibility

About

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).

Full 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).

Enrollment: 290 estimated patients

Sex: All

Ages: 22 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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290 participants in 2 patient groups

Standard Care plus ARDCs

Experimental group

Description:

* 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

Treatment:

Device: ADRCs

Other: standard care

Standard Care plus Placebo

Active Comparator group

Description:

* 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

Treatment:

Other: Placebo

Other: standard care