Trial to Assess Chelation Therapy in Critical Limb Ischemia

Part of paid clinical trials in Miami Beach, Florida.

Sponsor
Mt. Sinai Medical Center, Miami
Study ID
NCT03982693
Phase
PHASE3
Status
Recruiting
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Conditions

  • Critical Limb Ischemia
  • Diabetes

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Edetate Disodium — DRUG
    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.
  • Placebo — OTHER
    Placebo infusions consist of 500 ml normal saline.

Study Details

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 Dates

Start date
Mar 19, 2019
Status verified
Aug 2024
Primary completion
Dec 31, 2024
Completion
Jul 31, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active
    edetate disodium (EDTA)dff active infusion
  • Placebo Comparator: Placebo
    Placebo infusion

Primary Outcome Measure

Prevention of major cardiovascular endpoints [ Time Frame: 3 years (average follow-up 1.25 years) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai Medical CenterMiami BeachFlorida33140
Francisco Ujueta, MD
[email protected]
305-674-2162
Beatriz Acevedo
[email protected]
305-674-2162

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By research site
Mount Sinai Medical Center· Miami Beach, FL

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