A Phase 3 interventional study of ADRCs and standard care in Diabetic Foot Ulcer, sponsored by Paracrine, INC.. Not yet recruiting. Open to participants aged 22 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-28.
Sponsored by Paracrine, INC. · Phase 3, Interventional, and Treatment
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).
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).
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 290 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Paracrine, INC. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* 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 · Other: standard care
* 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 · Other: Placebo
Administration of Autologous Adipose Derived Regenerative Cells into the Diabetic Foot Ulcer
standard care
placebo
DFU Closure Rate
The rate of closure at 12 Weeks
Time frame: 12 Weeks
Percent Reduction of Wound Area
Percent Reduction of Wound Area from Baseline to 12 Weeks for Ulcers not Completely Healed
Time frame: 12 Weeks
No study locations are listed for this record.
Plan to share: No — No IPD/PHI will be made available
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Paracrine, INC.