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NCT05095389 Clinical Trial

Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

— ASCEND  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05095389
Other study ID # 2021-01
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date February 28, 2023
Est. completion date July 2025

Study information
Verified date October 2021
Source Paracrine, INC.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 290
Est. completion date July 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 22 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• ADRCs
Administration of Autologous Adipose Derived Regenerative Cells into the Diabetic Foot Ulcer
Other:
• standard care
standard care
• Placebo
placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Paracrine, INC.

Outcome
Type Measure Description Time frame Safety issue
Primary DFU Closure Rate The rate of closure at 12 Weeks 12 Weeks
Secondary Percent Reduction of Wound Area Percent Reduction of Wound Area from Baseline to 12 Weeks for Ulcers not Completely Healed 12 Weeks
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