Diabetic Foot Ulcer
Conditions
Keywords
Diabetic Foot Ulcer, DFU, Non-healing Foot Ulcer
Brief 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).
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).
Interventions
DEVICEADRCs
Administration of Autologous Adipose Derived Regenerative Cells into the Diabetic Foot Ulcer
OTHERstandard care
standard care
OTHERPlacebo
placebo
Sponsors
Paracrine, INC.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Placebo is visually indistinguishable from Active Treatment. Every patient receives Standard Care, plus either Active Treatment or Placebo.
Intervention model description
Randomized, Parallel-Group, Double-Blind, Placebo Controlled
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DFU Closure Rate | 12 Weeks | The rate of closure at 12 Weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Reduction of Wound Area | 12 Weeks | Percent Reduction of Wound Area from Baseline to 12 Weeks for Ulcers not Completely Healed |
Outcome results
None listed