Trial to Assess Chelation Therapy in Critical Limb Ischemia — TACT3a  

Diabetes Clinical Trial

Official title: Trial to Assess Chelation Therapy in Critical Limb Ischemia

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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.

The study plans to enroll 50 patients with diabetes and critical limb ischemia (CLI) to prevent the major cardiovascular endpoints of major amputation, coronary revascularization, stroke, Myocardial Infarction (MI), or death (all-cause) during an average 1.25 years of follow-up. Patients will be randomly assigned to chelation or placebo with a 3:2 (30 active, 20 placebo) allocation ratio. Treatment will consist of 40 active or placebo infusions over 30 weeks. Active therapy will be the same edetate disodium-based infusion used safely and successfully in a previous published study, Trial to Assess Chelation Therapy (TACT). Baseline and post infusion urine metals will be collected. Following the final infusion, patients will be contacted quarterly until the end of the study. ;

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Critical Limb Ischemia
• Diabetes
• Ischemia

• NCT number: NCT03982693
• Study type: Interventional
• Source: Mt. Sinai Medical Center, Miami
• Contact: Francisco Ujueta, MD
• Phone: 305-674-2162
• Email: Francisco.Ujueta@msmc.com
• Status: Recruiting
• Phase: Phase 3
• Start date: March 19, 2019
• Completion date: July 2024