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

September 26, 2022 updated by: Paracrine, INC.

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

290

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard Care plus ARDCs
  • 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
Other: standard care
standard care
Device: ADRCs
Administration of Autologous Adipose Derived Regenerative Cells into the Diabetic Foot Ulcer
Active Comparator: Standard Care plus 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
Other: Placebo
placebo
Other: standard care
standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFU Closure Rate
Time Frame: 12 Weeks
The rate of closure at 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Reduction of Wound Area
Time Frame: 12 Weeks
Percent Reduction of Wound Area from Baseline to 12 Weeks for Ulcers not Completely Healed
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paracrine, INC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 28, 2023

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

October 15, 2021

First Submitted That Met QC Criteria

October 26, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD/PHI will be made available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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