Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers (ASCEND)
Diabetic Foot Ulcer
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic Foot Ulcer, DFU, Non-healing Foot Ulcer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Standard Care plus ARDCs
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 ADRC arm will receive ADRCs
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