RECRUITING

Trial to Assess Chelation Therapy in Critical Limb Ischemia

Conditions

Critical Limb Ischemia Diabetes Chelation

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Trial to Assess Chelation Therapy in Critical Limb Ischemia

Quick Facts

Study Start:2019-03-19

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03982693

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* \<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.

Inclusion Criteria

Exclusion 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.

* \<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.

Contacts and Locations

Study Contact

Francisco Ujueta, MD

CONTACT

305-674-2162

Francisco.Ujueta@msmc.com

Beatriz Acevedo

CONTACT

305-674-2162

Beatriz.Acevedo@msmc.com

Principal Investigator

Gervasio Lamas, MD

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Mount Sinai Medical Center

Miami Beach, Florida, 33140

United States

Collaborators and Investigators

Sponsor: Mt. Sinai Medical Center, Miami

Gervasio Lamas, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-19

Study Completion Date2025-07

Study Record Updates

Study Start Date2019-03-19

Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

Chelation
Critical Limb Ischemia
Diabetes

Additional Relevant MeSH Terms

Critical Limb Ischemia
Diabetes