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 trial tests whether chelation therapy — infusions of a chemical called EDTA that binds to and removes heavy metals from the body — can improve circulation and wound healing in diabetic patients with critical limb ischemia (CLI). CLI is a severe condition where blocked arteries in the leg cause rest pain, non-healing wounds, and risk of amputation. Some patients are not eligible for conventional revascularization surgery or have already had it fail, leaving few options. Participants receive a series of chelation infusions or placebo infusions over several months. The study tracks limb salvage rates, wound healing, pain, and quality of life. You may be eligible if: - You are 50 or older - You have diabetes and confirmed severe narrowing of leg arteries below the knee - You have critical limb ischemia (rest pain or non-healing wounds for at least 2 weeks) - You are not a candidate for, or have failed, revascularization surgery You may NOT be eligible if: - You have active infection, gangrene above the foot joints, or severe uncontrollable pain - You have significant kidney impairment (eGFR below 30) - You have smoked in the last 3 months - You are a woman of childbearing potential - You have active heart failure or were hospitalized for heart failure in the last 3 months Talk to your doctor to see if this trial is right for you.

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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