Chelation Therapy for Critical Limb Ischemia
(TACT3a Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have had prior intravenous chelation therapy or oral chelation with an FDA-approved agent, there are specific time restrictions before you can participate.
What data supports the effectiveness of the drug edetate disodium for treating critical limb ischemia?
Is chelation therapy with edetate disodium safe for humans?
In a small study with patients having diabetes and critical limb ischemia, edetate disodium-based infusions showed preliminary evidence of safety, with no major adverse cardiovascular events reported during the treatment and follow-up period. However, other sources mention potential toxic effects that could be dangerous, so more research is needed to confirm its safety.12356
How does the drug edetate disodium differ from other treatments for critical limb ischemia?
Research Team
Gervasio Lamas, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
This trial is for diabetic patients over 50 with critical limb ischemia, who have severe artery blockages in their legs and are not candidates for surgery. They must have had pain or non-healing wounds due to poor blood flow for at least two weeks. Smokers or those with recent heart failure, severe kidney disease, certain metabolic disorders, active infections, or a history of chelation therapy are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 40 active or placebo infusions over 30 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with quarterly contacts until the end of the study
Treatment Details
Interventions
- Edetate Disodium
- Placebo
Edetate Disodium is already approved in United States, European Union for the following indications:
- Lead poisoning
- Cardiovascular events including amputation in high-risk diabetic patients
- Lead poisoning
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mt. Sinai Medical Center, Miami
Lead Sponsor