Trial to Assess Chelation Therapy in Critical Limb Ischemia

PHASE3RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 19, 2019

Primary Completion Date

December 31, 2024

Study Completion Date

July 31, 2025

Conditions
Critical Limb IschemiaDiabetes
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.

Trial Locations (1)

33140

RECRUITING

Mount Sinai Medical Center, Miami Beach

All Listed Sponsors
lead

Mt. Sinai Medical Center, Miami

OTHER