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Can Metal-Stripping infusions save diabetic limbs and hearts?

NCT ID NCT03982693

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This trial tests whether a chelation therapy infusion—a cocktail that removes toxic metals from the blood—can reduce the risk of heart attacks, strokes, and leg amputations in people with diabetes and critical limb ischemia (severe blockage in leg arteries). Half of the 50 participants receive the active chelation infusion; the other half receive a placebo (salt water). The study aims to see if cleaning out environmental metals can improve outcomes in this high-risk group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
edetate disodium (chelation therapy)
What this could lead to
If it works, this could offer a new way to prevent major cardiovascular events and amputations in diabetic patients with severe leg artery disease.
What could go wrong
This is a relatively small phase 3 trial, and chelation therapy is controversial with mixed prior results. It may not prove effective or could cause side effects from the infusion components.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2019

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 50 years * History of diabetes, defined as medical record evidence or patient report of currently using insulin or oral hypoglycemic agents, or with a history of fasting blood glucose measurement of 126 mg/dL or higher, or a history of HbA1c of 6.5% or higher. * Significant stenosis (≥ 75%) of two or more infra-popliteal arteries in the affected limb as verified by at least one imaging technique (angiography, magnetic resonance angiogram, coronary computed tomography angiogram, or doppler examination) within 6 months prior to enrollment; * History of CLI defined as moderate or high-risk infra-popliteal chronic critical limb ischemia (Rutherford Clinical Severity Score 4 or 5) defined as: * The presence of rest pain or non-healing ulceration or gangrene for at least 2 weeks plus documentation of severely compromised tissue perfusion: * If there is tissue loss, a resting ankle systolic pressure of ≤ 60 mmHg in the affected limb; or a resting toe systolic pressure of ≤ 40 mmHg or a tissue perfusion pressure (TPP) \<40 mmHg. * If there is no tissue loss, a resting ankle pressure of ≤ 50 mmHg or resting toe systolic pressure of ≤ 30 mmHg or a tissue perfusion pressure (TPP) \< 30 mmHg. * Not a candidate or a failed candidate for surgical or transcatheter revascularization; * Able to give informed consent. Exclusion Criteria: * \<7 days following lower extremity (infra-popliteal), carotid, or coronary revascularization. * Arterial insufficiency in the lower extremity as the result of a non-atherosclerotic disorder. * Subjects with evidence of active infection (e.g., cellulitis, osteomyelitis) or deep ulceration exposing bone or tendon or extensive heel ulceration * Subjects with extensive gangrene extending above the MT joint * Subjects in whom there is severe pain at rest uncontrollable with pain medications * Prior intravenous chelation therapy consisting of \> 1 infusion within 5 years; if only 1 infusion took place, patient cannot be enrolled for at least 12 months after said infusion. * Oral chelation with an FDA-approved chelating agent within 2 years * Allergy to any components of the study drug * Planned leg revascularization within 1 month of enrollment * Symptomatic or clinically evident acute heart failure * Heart failure hospitalization within 3 months * Blood pressure \>160/100 * No venous access * eGFR \< 30 mL/min per 1.73 m2 or lower (CKD stages 1-3) calculated with MDRD * Known or suspected acute kidney injury using prevalent KDIGO criteria45 * Platelet count \<100,000/mm3 * Cigarette smoking within the last 3 months * Liver disease or Alanine aminotransferase (ALT), aspartate aminotransferase (AST) \> 2.0 times the upper limit of normal (this will require clearance by the Study PI) * Diseases of copper, iron, or calcium metabolism (other than osteopenia or osteoporosis, or simple iron deficiency). These require evaluation by the Study PI * Inability to tolerate the study-required fluid load * Other medical condition likely to affect patient survival within 3 years * Women of child-bearing potential * Any factor that suggests that the potential participant will not be able to adhere to the protocol.

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Conditions

The condition(s) this trial relates to.

Chronic Limb-Threatening Ischemia diabetes mellitus limb ischemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.