Trial to Assess Chelation Therapy in Critical Limb Ischemia

Exclusion Criteria

• •\<7 days following lower extremity (infra-popliteal), carotid, or coronary revascularization.
• •Arterial insufficiency in the lower extremity as the result of a non-atherosclerotic disorder.
• •Subjects with evidence of active infection (e.g., cellulitis, osteomyelitis) or deep ulceration exposing bone or tendon or extensive heel ulceration
• •Subjects with extensive gangrene extending above the MT joint
• •Subjects in whom there is severe pain at rest uncontrollable with pain medications
• •Prior intravenous chelation therapy consisting of \> 1 infusion within 5 years; if only 1 infusion took place, patient cannot be enrolled for at least 12 months after said infusion.
• •Oral chelation with an FDA-approved chelating agent within 2 years
• •Allergy to any components of the study drug
• •Planned leg revascularization within 1 month of enrollment
• •Symptomatic or clinically evident acute heart failure
• •Heart failure hospitalization within 3 months
• •Blood pressure \>160/100
• •No venous access
• •eGFR \< 30 mL/min per 1.73 m2 or lower (CKD stages 1-3) calculated with MDRD
• •Known or suspected acute kidney injury using prevalent KDIGO criteria45
• •Platelet count \<100,000/mm3
• •Cigarette smoking within the last 3 months
• •Liver disease or Alanine aminotransferase (ALT), aspartate aminotransferase (AST) \> 2.0 times the upper limit of normal (this will require clearance by the Study PI)
• •Diseases of copper, iron, or calcium metabolism (other than osteopenia or osteoporosis, or simple iron deficiency). These require evaluation by the Study PI
• •Inability to tolerate the study-required fluid load
• •Other medical condition likely to affect patient survival within 3 years
• •Women of child-bearing potential
• •Any factor that suggests that the potential participant will not be able to adhere to the protocol.