Status:
COMPLETED
Chelation Therapy in Diabetic Patients With Critical Limb Ischemia
Lead Sponsor:
Mt. Sinai Medical Center, Miami
Conditions:
Critical Limb Ischemia
Peripheral Arterial Disease
Eligibility:
All Genders
50+ years
Phase:
EARLY_PHASE1
Brief Summary
This is a Pilot Trial Using Chelation Therapy for Limb Preservation in Diabetic Patients with Critical Limb Ischemia.
Detailed Description
The purpose of this research study is to evaluate the effect of ethylenediaminetetraacetic acid (EDTA) based chelation therapy plus vitamins in diabetic patients with severe peripheral artery disease ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03424746
Start Date
August 1 2015
End Date
February 18 2019
Last Update
June 10 2019
Active Locations (1)
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1
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140