Clinical Trials

Inclusion Criteria:

• Age 18 to 85 inclusive, currently receiving standard of care wound treatment for chronic wounds or gangrene including as indicated:
  • debridement,
  • pressure offloading,
  • infection control, and/or
  • maintenance of a moist wound environment.
• Diagnosis of advanced peripheral artery disease (PAD) with tissue loss (ulceration and/or dry gangrene)
• Post intervention inclusion criteria include a successful open bypass grafting or endovascular intervention of an infrapopliteal lesion(s) on the same leg that has tissue loss without significant improvement in toe brachial index (TBI) post intervention. The following will be accepted as demonstrating a lack of post intervention toe brachial index (TBI) improvement:
  • toe brachial index (TBI) ≤ 0.51
  • Toe pressure < 50 mmHg with flat or dampened wave forms
  • Skin Perfusion pressure < 40 mmHg at mid foot level

Exclusion Criteria:

• Previous major amputation of the leg to be treated or planned major amputation or transmetatarsal amputation within the first month following enrollment.
• Only a short segment superficial femoral artery lesion - consistent with Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) A or B category, and no infrapopliteal disease
• Staged or planned intervention in the index leg within 30 days after the index procedure
• Acute limb-threatening ischemia, trauma, known non-atherosclerotic vascular disease
• Non-salvageable limb defined as major tissue loss and an unsalvageable foot;
• Clinical evidence of invasive infection in the index leg
• Inability to safely perform a revascularization procedure due to uncontrolled diabetes or other medical condition.