SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease

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;
• •Wounds that have decreased in size by \>50% between the Screening visit and Day 0.
• •If patient has active infection of the index limb that is being treated, and, in the opinion of treating physician, will not lead to an amputation within the next 3 months, the patient can be enrolled.
• •Inability to safely perform a revascularization procedure due to uncontrolled diabetes or other medical condition.
• •Presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial