RecruitingPhase 3NCT03982693

Trial to Assess Chelation Therapy in Critical Limb Ischemia


Sponsor

Mt. Sinai Medical Center, Miami

Enrollment

50 participants

Start Date

Mar 19, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Edetate Disodium and Placebo for people with critical limb ischemia and diabetes. The study is currently recruiting participants at 1 location. People eligible for this study include aged 50 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEdetate Disodium

The solution contains up to 3 g of edetate disodium adjusted based on creatinine clearance, 2 g of magnesium chloride, 100 mg of procaine hydrochloride, 2500 U of heparin, 7 g of ascorbate, 2 milliequivalent (mEq) potassium chloride (KCl), 840 mg sodium bicarbonate, 250 mg pantothenic acid, 100 mg of thiamine, 100 mg of pyridoxine, and sterile water to complete 500 mL.

OTHERPlacebo

Placebo infusions consist of 500 ml normal saline.


Locations(1)

Mount Sinai Medical Center

Miami Beach, Florida, United States

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NCT03982693


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