Trial to Assess Chelation Therapy in Critical Limb Ischemia (TACT3a)

STATUS

Recruiting
End date

Mar 25, 2023
participants needed

50
sponsor

Mt. Sinai Medical Center, Miami

Send

Updated on 9 February 2022

See if I qualify

diabetes

angiography

stenosis

insulin

fasting

fasting blood glucose

ischemia

hemoglobin a1c

glycosylated hemoglobin

gangrene

limb ischemia

rest pain

healing ulceration

hypoglycemic agents

oral hypoglycemic

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.

Description

The study plans to enroll 50 patients with diabetes and critical limb ischemia (CLI) to prevent the major cardiovascular endpoints of major amputation, coronary revascularization, stroke, Myocardial Infarction (MI), or death (all-cause) during an average 1.25 years of follow-up. Patients will be randomly assigned to chelation or placebo with a 3:2 (30 active, 20 placebo) allocation ratio. Treatment will consist of 40 active or placebo infusions over 30 weeks. Active therapy will be the same edetate disodium-based infusion used safely and successfully in a previous published study, Trial to Assess Chelation Therapy (TACT). Baseline and post infusion urine metals will be collected. Following the final infusion, patients will be contacted quarterly until the end of the study.

Details

Condition	Critical Limb Ischemia, Diabetes
Treatment	Placebo, Edetate Disodium, Edetate Disodium
Clinical Study Identifier	NCT03982693
Sponsor	Mt. Sinai Medical Center, Miami
Last Modified on	9 February 2022

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Eligibility		Yes	No	Not Sure
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 pressure of 40 mmHg or a tissue perfusion pressure (TPP) <40 mmHg
	If there is no tissue loss, a resting ankle pressure of 50 mmHg or resting toe systolic pressure of 30 mmHg or a tissue perfusion pressure (TPP) < 30 mmHg
	Not a candidate or a failed candidate for surgical or transcatheter revascularization
	Able to give informed consent
Exclusion Criteria
	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 Metatarsophalangeal (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
	Coronary or carotid revascularization within 3 months
	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
	Estimated glomerular filtration ratee (GFR) < 30 mL/min per 1.73 m2 or lower (CKD stages 1-3) calculated with the Modification of Diet in Renal Disease Study (MDRD) equation
	Known or suspected acute kidney injury using prevalent Kidney Disease: Improving Global Outcomes (KDIGO) criteria
	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

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Trial to Assess Chelation Therapy in Critical Limb Ischemia (TACT3a)