Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers

Study Overview
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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).

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).

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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: ADRCs
* Other: standard care
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Parallel-Group, Double-Blind, Placebo Controlled
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot Ulcer, DFU, Non-healing Foot Ulcer