Actively Recruiting

Phase 3
Age: 50Years +
All Genders
NCT03982693

Trial to Assess Chelation Therapy in Critical Limb Ischemia

Led by Mt. Sinai Medical Center, Miami · Updated on 2024-08-21

50

Participants Needed

1

Research Sites

328 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Trial to Assess Chelation Therapy in Critical Limb Ischemia

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 years or older
  • History of diabetes confirmed by medical records or current use of insulin or oral hypoglycemic agents, or fasting blood glucose ≥ 126 mg/dL, or HbA1c ≥ 6.5%
  • Significant narrowing (≥ 75%) of two or more infra-popliteal arteries in the affected limb verified by imaging within 6 months
  • Moderate or high-risk critical limb ischemia (Rutherford Clinical Severity Score 4 or 5) with rest pain or non-healing ulcers lasting at least 2 weeks plus severely reduced tissue blood flow
  • Not a candidate or has failed surgical or catheter-based revascularization
  • Able to give informed consent
Not Eligible

You will not qualify if you...

  • Less than 7 days since lower extremity, carotid, or coronary revascularization
  • Arterial insufficiency caused by non-atherosclerotic disorders
  • Active infection such as cellulitis, osteomyelitis, deep ulcers exposing bone or tendon, or extensive heel ulcers
  • Extensive gangrene above the metatarsophalangeal joint
  • Severe uncontrollable rest pain
  • More than 1 intravenous chelation infusion in past 5 years or oral chelation in past 2 years
  • Allergy to any study drug components
  • Planned leg revascularization within 1 month
  • Symptomatic or clinical acute heart failure or heart failure hospitalization within 3 months
  • Blood pressure over 160/100 mmHg
  • No available venous access
  • Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2
  • Known or suspected acute kidney injury
  • Platelet count below 100,000/mm3
  • Smoking within last 3 months
  • Liver disease or liver enzyme levels over twice normal without clearance by study doctor
  • Diseases affecting copper, iron, or calcium metabolism (except mild bone loss or simple iron deficiency) without evaluation by study doctor
  • Unable to tolerate required fluid intake
  • Other serious medical conditions likely to affect survival within 3 years
  • Women who can become pregnant
  • Any factor suggesting inability to follow study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mount Sinai Medical Center

Miami Beach, Florida, United States, 33140

Actively Recruiting

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Research Team

F

Francisco Ujueta, MD

CONTACT

B

Beatriz Acevedo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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