NCT03982693 Trial to Assess Chelation Therapy in Critical Limb Ischemia
| NCT ID | NCT03982693 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Mt. Sinai Medical Center, Miami |
| Condition | Critical Limb Ischemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2019-03-19 |
| Primary Completion | 2024-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
TACT3a is a double blind, placebo-controlled, randomized trial to test a novel therapy, edetate disodium-based chelation of environmentally acquired toxic metals, to reduce cardiovascular events including amputation in high-risk diabetic patients.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 50 years * History of diabetes, defined as medical record evidence or patient report of currently using insulin or oral hypoglycemic agents, or with a history of fasting blood glucose measurement of 126 mg/dL or higher, or a history of HbA1c of 6.5% or higher. * Significant stenosis (≥ 75%) of two or more infra-popliteal arteries in the affected limb as verified by at least one imaging technique (angiography, magnetic resonance angiogram, coronary computed tomography angiogram, or doppler examination) within 6 months prior to enrollment; * History of CLI defined as 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 or gangrene for at least 2 weeks plus documentation of severely compromised tissue perfusion: * If there is tissue loss, a resting ankle systolic pressure of ≤ 60 mmHg in the affected limb; or a resting toe systolic press