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RECRUITING
NCT03982693
PHASE3

Trial to Assess Chelation Therapy in Critical Limb Ischemia

Sponsor: Mt. Sinai Medical Center, Miami

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2019-03-19

Completion Date

2025-07

Last Updated

2024-08-21

Healthy Volunteers

No

Interventions

DRUG

Edetate 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.

OTHER

Placebo

Placebo infusions consist of 500 ml normal saline.

Locations (1)

Mount Sinai Medical Center

Miami Beach, Florida, United States