Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2025-07-31

Brief Summary

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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).

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Detailed Description

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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

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Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, Parallel-Group, Double-Blind, Placebo Controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Placebo is visually indistinguishable from Active Treatment. Every patient receives Standard Care, plus either Active Treatment or Placebo.

Study Groups

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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

Group Type EXPERIMENTAL

ADRCs

Intervention Type DEVICE

Administration of Autologous Adipose Derived Regenerative Cells into the Diabetic Foot Ulcer

standard care

Intervention Type OTHER

standard care

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

Group Type ACTIVE_COMPARATOR

standard care

Intervention Type OTHER

standard care

Placebo

Intervention Type OTHER

placebo

Interventions

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ADRCs

Administration of Autologous Adipose Derived Regenerative Cells into the Diabetic Foot Ulcer

Intervention Type DEVICE

standard care

Intervention Type OTHER

Placebo

placebo

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No