Exploratory Study of the Efficacy of Standard of Care Revascularization of the Lower Extremity

Exclusion Criteria

• •1. Inability to undergo angiogram with revascularization
• •2. Unilateral neuropathic findings or symptoms
• •3. Vitamin B-12 level \< 400 pg/ml (historical results allowed if performed within the past 30 days) \*
• •4. Known causes of peripheral neuropathy other than diabetes, e.g., Amyloidosis, Tangier disease, Fabry's disease, hereditary sensory autonomic neuropathy, alcohol-related neuropathy, drug-induced neuropathy (e.g., chemotherapy, antibiotics, anti-retroviral agents, other neurotoxic agents) hypothyroidism that is not well controlled, rheumatoid arthritis or autoimmune disorders requiring treatment with corticosteroids, anti-tumor necrosis factor or immune-modulating medicines
• •5. Known history of Hepatitis B, C, or HIV
• •6. Lower limb amputation, including toe
• •7. Lower extremity inoperable occlusive vascular disease
• •8. Inability to provide informed consent
• •9. History of bleeding disorders
• •10. History of diabetic ulcers to the lower extremities
• •11. History of any surgical bypass of the lower extremities prior to randomization
• •12. History of previous revascularization of the lower extremities prior to randomization
• •13. End Stage Renal Disease (ESRD) requiring or on dialysis
• •14. Thyroid Stimulating Hormone -TSH \>10.0 uu/mL\*
• •15. Potassium \> 5.5 mmol/L. \*
• •16. Calcium \< 8.5 mg/dL or \> 11mg/dL \*
• •17. Hemoglobin \< 9.0 g/dL \*
• •18. Female that is pregnant, breastfeeding or intends to become pregnant during the study period
• •19. Clinically significant abnormal ECG findings, in the opinion of the Investigator
• •20. Participation in another clinical trial with investigational drug or device at time of screening
• •21. Any other clinically significant disorders or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the protocol requirements