50 Participants Needed

Chelation Therapy for Critical Limb Ischemia

(TACT3a Trial)

BA
FU
Overseen ByFrancisco Ujueta, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Mt. Sinai Medical Center, Miami
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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?

A small pilot study showed that edetate disodium-based infusions might help improve wound healing and quality of life in patients with diabetes and critical limb ischemia, suggesting a potential benefit and preliminary evidence of safety.12345

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?

Edetate disodium is unique because it is a chelation therapy that involves intravenous infusions to remove toxic metals from the body, which may improve blood flow and promote wound healing in patients with critical limb ischemia, especially those with diabetes.12357

Research Team

GL

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

I am 50 years old or older.
I have severe narrowing in two or more arteries below my knee confirmed by a scan within the last 6 months.
I have diabetes, as shown by my use of insulin or oral medications, or my blood sugar or HbA1c levels.
See 3 more

Exclusion Criteria

I had surgery to improve blood flow in my legs, neck, or heart less than a week ago.
I have severe pain that can't be controlled with medication.
I am a woman who can become pregnant.
See 20 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 40 active or placebo infusions over 30 weeks

30 weeks
40 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with quarterly contacts until the end of the study

1.25 years
Quarterly contacts

Treatment Details

Interventions

  • Edetate Disodium
  • Placebo
Trial OverviewThe TACT3a study is testing whether edetate disodium can reduce cardiovascular events including amputation in high-risk diabetic patients with critical limb ischemia. Participants will be randomly assigned to receive either the actual drug or a placebo without knowing which one they're getting (double-blind).
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
edetate disodium (EDTA)dff active infusion
Group II: PlaceboPlacebo Group1 Intervention
Placebo infusion

Edetate Disodium is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Edetate Disodium for:
  • Lead poisoning
  • Cardiovascular events including amputation in high-risk diabetic patients
🇪🇺
Approved in European Union as Edetate Disodium for:
  • Lead poisoning

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mt. Sinai Medical Center, Miami

Lead Sponsor

Trials
19
Recruited
4,100+

Findings from Research

In a pilot study involving 10 patients with diabetes and critical limb ischemia, edetate disodium-based infusions showed potential benefits, including complete wound healing and improved quality of life, with no major adverse cardiovascular events reported during treatment and follow-up.
The study suggests that edetate disodium may be a safe therapeutic option for patients with severe diabetic limb disease, warranting further investigation in a larger randomized controlled trial (TACT3a) to confirm these preliminary findings.
Limb Preservation Using Edetate Disodium-based Chelation in Patients with Diabetes and Critical Limb Ischemia: An Open-label Pilot Study.Arenas, I., Ujueta, F., Diaz, D., et al.[2020]
TACT2 is a large clinical trial involving 1000 patients with diabetes and a history of myocardial infarction, testing the effects of 40 weekly infusions of edetate disodium on cardiovascular events over a follow-up period of 2.5 to 5 years.
The trial aims to confirm previous findings that chelation therapy can reduce cardiovascular events, with a focus on understanding whether the benefits are linked to the removal of toxic metals like lead and cadmium from the body.
The trial to assess chelation therapy 2 (TACT2): Rationale and design.Lamas, GA., Anstrom, KJ., Navas-Acien, A., et al.[2023]
In a study of 633 patients with diabetes who had previously experienced a heart attack, treatment with edetate disodium significantly reduced the risk of serious cardiovascular events compared to placebo, with a hazard ratio of 0.59, indicating a 41% lower risk.
Patients on insulin therapy showed the greatest benefit from edetate disodium treatment, with a 58% reduction in the primary endpoint of cardiovascular events compared to those receiving placebo, suggesting that insulin users may respond better to this therapy.
Possible differential benefits of edetate disodium in post-myocardial infarction patients with diabetes treated with different hypoglycemic strategies in the Trial to Assess Chelation Therapy (TACT).Escolar, E., Ujueta, F., Kim, H., et al.[2022]

References

Limb Preservation Using Edetate Disodium-based Chelation in Patients with Diabetes and Critical Limb Ischemia: An Open-label Pilot Study. [2020]
The trial to assess chelation therapy 2 (TACT2): Rationale and design. [2023]
Possible differential benefits of edetate disodium in post-myocardial infarction patients with diabetes treated with different hypoglycemic strategies in the Trial to Assess Chelation Therapy (TACT). [2022]
Edetate Disodium-Based Treatment for Secondary Prevention in Post-Myocardial Infarction Patients. [2019]
Chelation treatment of atherosclerosis. [2021]
Chelation therapy to prevent diabetes-associated cardiovascular events. [2019]
Chelation therapy of atherosclerosis. [2019]