Can Metal-Stripping infusions save diabetic limbs and hearts?
NCT ID NCT03982693
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Critical limb ischemia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
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.
- New pill takes aim at blood sugar in diabetes
- Home c-peptide tests could reveal hidden insulin production in diabetes
- Brain scans may predict who is most at risk for dangerous low blood sugar
- Diabetes devices put to the test: can home monitors match lab accuracy?
- Can weekly groceries and group coaching help control diabetes?
- Island-Wide blood sugar testing aims to map hidden diabetes