Chelation Therapy in Diabetic Patients With Critical Limb Ischemia

• Status: Completed
• Trial end date: 2019-02-18
• Target enrollment: 0
• Participant gender: All

Summary

This is a Pilot Trial Using Chelation Therapy for Limb Preservation in Diabetic Patients with Critical Limb Ischemia.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mt. Sinai Medical Center, Miami
• Treatments: Edetic Acid; Pentetic Acid

Criteria

Inclusion Criteria:

• Male or female older than 50 years of age;

• On treatment for diabetes mellitus, or fasting glucose 126 mg/dL or higher, or self-identified as diabetic

• Diagnostic of moderate or high-risk infra-popliteal chronic critical limb ischemia (Rutherford Clinical Severity Score 4 or 5) defined as:

• The presence of rest pain or non-healing ulceration for at least 2 weeks plus:

• A resting ankle systolic pressure (in either the dorsalis pedis or posterior tibial arteries) of ≤60 mmHg in the affected limb); or

• A resting toe systolic pressure of ≤40 mmHg in the affected limb or

• Skin perfusion pressure of ≤40 mmHg in the affected limb

• Significant stenosis (≥75%) of two or more infra-popliteal arteries in the affected limb as verified by one imaging technique (angiography, magnetic resonance angiography (MRA), computed tomographic angiography (CTA) or doppler examination) within 6 months prior to enrollment;

• Patients able to give informed consent.

Exclusion Criteria:

• Arterial insufficiency or ulcer in the lower extremity as the result of a non-atherosclerotic disorder.

• Subjects with evidence of active osteomyelitis or deep ulceration exposing bone or tendon in the extremity planned for treatment;

• Subjects in whom there is extensive heel ulceration

• Intravenous chelation therapy within 1 year (>5 infusions)

• Allergy to any study drug

• Symptomatic or clinically evident heart failure

• Heart failure hospitalization within 6 months

• Blood pressure >160/100

• No venous access

• Serum creatinine >2.0 mg/dL

• Platelet count <100000/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

• Diseases of copper, iron, or calcium metabolism

• Inability to tolerate the study-required fluid load

• Inability to keep to study schedules

• Medical condition likely to affect patient survival within 4 years

• Women of child-bearing potential