TACT3a.

Study name	Trial to Assess Chelation Therapy in Critical Limb Ischemia (TACT3a)
Methods	Phase 3, double‐blind, RCT
Participants	50 participants with diabetes and critical limb ischaemia
Interventions	Drug: edetate disodium: (chelation) 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. Placebo infusions consist of 500 mL normal saline. Treatment will consist of 40 active or placebo infusions over 30 weeks.
Outcomes	Coronary revascularization, stroke, MI, death (all‐cause), or major amputation during an average 1.25 years of follow‐up
Starting date	19 March 2019
Contact information	Francisco Ujueta, MD, Mount Sinai Medical Center, Miami, Florida, United States
Notes	Expected completion in 2022

EDTA: ethylene diamine tetra‐acetic acid
OMVM; oral multi vitamins/minerals
RCT: randomised controlled trial