Chelation Therapy in Diabetic Patients With Critical Limb Ischemia

Completed · Early Phase 1

Conditions studied: Critical Limb Ischemia, Peripheral Arterial Disease

In brief

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

Key facts

Study ID

NCT03424746

Run by

Mt. Sinai Medical Center, Miami

People needed

11

Starts

2015-08-01

Expected to finish

2019-02-18

Last updated by the study team

2019-06-10

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Mount Sinai Medical Center — Miami Beach, Florida, United States

Full record on ClinicalTrials.gov

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