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Chelation Therapy in Diabetic Patients With Critical Limb Ischemia (TACT-PAD)

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ClinicalTrials.gov Identifier: NCT03424746
Recruitment Status : Completed
First Posted : February 7, 2018
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami

Brief Summary:
This is a Pilot Trial Using Chelation Therapy for Limb Preservation in Diabetic Patients with Critical Limb Ischemia.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Peripheral Arterial Disease Drug: disodium EDTA Early Phase 1

Detailed Description:

The purpose of this research study is to evaluate the effect of ethylenediaminetetraacetic acid (EDTA) based chelation therapy plus vitamins in diabetic patients with severe peripheral artery disease presenting with impending amputation and determine if there is an improvement in outcomes and a delay or reduction of amputations.

The investigators propose to enroll 10 patients in an open-label study of TACT-formula, EDTA-based chelation therapy + commercially available TACT oral multi vitamins, delivering 40-50 infusions over 1 year. Clinical assessment, and noninvasive blood flow assessments will be performed at baseline, and at completion of 20 and 40 infusions. HIPAA-compliant photographs of the affected lower limbs will be taken at each infusion visit.

The specific aims of this open-label pilot study are to:

  1. Assess the effect of EDTA-based chelation therapy plus vitamins in diabetic patients with below-the-knee peripheral artery disease presenting with impending amputation and determine if there is an improvement in vascular flow parameters, such that the scheduled amputation can be averted or reduced in extent.
  2. Co-primary severity endpoint: Changes in pain scores, quality of life, wound severity, segmental lower extremity pressures and endothelial function.
  3. Assess safety of EDTA-based chelation therapy in this patient population, defined as deterioration of renal function, symptomatic hypocalcemia or hypoglycemia within 8 hours of each infusion, or Class 4 heart failure within 24 hours of an infusion.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Trial of Limb Preservation Using Chelation Therapy in Diabetic Patients With Critical Limb Ischemia
Actual Study Start Date : August 2015
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : February 18, 2019


Arm Intervention/treatment
Experimental: Open label EDTA chelation
EDTA-based chelation therapy plus vitamins in diabetic patients with severe peripheral artery disease presenting with impending amputation and determine if there is an improvement in outcomes and a delay or reduction of amputations.
Drug: disodium EDTA
Open-label study of TACT-formula, EDTA-based chelation therapy + commercially available TACT oral multi vitamins, delivering 40-50 infusions over 1 year.
Other Name: chelation therapy




Primary Outcome Measures :
  1. Improvement in vascular flow parameters [ Time Frame: 1 year ]
    Segmental lower extremity pressures including Skin Perfusion Pressure (SPP), Pulse Volume Recording (PVR) and ankle brachial index (ABI), will be obtained at baseline, after 20 and 40 infusions using the SensiLase PAD-IQ® . This test can be used to accurately detect the presence and severity of peripheral artery disease. Additionally, for patients entering the continued treatment phase, the test will be performed during infusion visits 45 and 50.

  2. Wound Evaluation [ Time Frame: 1 Year ]

    HIPAA-compliant pictures of skin integrity including wounds and areas of gangrene will be obtained for each patient at baseline and every 5 infusions. Wound assessment includes ulcer measurements (length, width, depth and undermining) and percentage of epithelialization.

    Additionally, for patients entering the continued treatment phase, wound evaluation will be performed during infusion visits 45 and 50.


  3. Peripheral Artery Questionnaire [ Time Frame: 1 Year ]
    The severity of PAD will be assessed at baseline, 20th and 40th infusions, with a Peripheral Arterial Questionnaire



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female older than 50 years of age;
  • On treatment for diabetes mellitus, or fasting glucose 126 mg/dL or higher, or self-identified as diabetic
  • Diagnostic of 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 for at least 2 weeks plus:
  • A resting ankle systolic pressure (in either the dorsalis pedis or posterior tibial arteries) of ≤60 mmHg in the affected limb); or
  • A resting toe systolic pressure of ≤40 mmHg in the affected limb or
  • Skin perfusion pressure of ≤40 mmHg in the affected limb
  • Significant stenosis (≥75%) of two or more infra-popliteal arteries in the affected limb as verified by one imaging technique (angiography, magnetic resonance angiography (MRA), computed tomographic angiography (CTA) or doppler examination) within 6 months prior to enrollment;
  • Patients able to give informed consent.

Exclusion Criteria:

  • Arterial insufficiency or ulcer in the lower extremity as the result of a non-atherosclerotic disorder.
  • Subjects with evidence of active osteomyelitis or deep ulceration exposing bone or tendon in the extremity planned for treatment;
  • Subjects in whom there is extensive heel ulceration
  • Intravenous chelation therapy within 1 year (>5 infusions)
  • Allergy to any study drug
  • Symptomatic or clinically evident heart failure
  • Heart failure hospitalization within 6 months
  • Blood pressure >160/100
  • No venous access
  • Serum creatinine >2.0 mg/dL
  • Platelet count <100000/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
  • Diseases of copper, iron, or calcium metabolism
  • Inability to tolerate the study-required fluid load
  • Inability to keep to study schedules
  • Medical condition likely to affect patient survival within 4 years
  • Women of child-bearing potential

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424746


Locations
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United States, Florida
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Sponsors and Collaborators
Mt. Sinai Medical Center, Miami
Investigators
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Principal Investigator: Gervasio Lamas, MD Mount Sinai Medical Center of Florida

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Responsible Party: Gervasio Lamas, MD, Chair, Department of Medicine- Chief, Division of Cardiology, Mt. Sinai Medical Center, Miami
ClinicalTrials.gov Identifier: NCT03424746     History of Changes
Other Study ID Numbers: 14-36-H-07
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Ischemia
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Edetic Acid
Pentetic Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antidotes
Protective Agents
Physiological Effects of Drugs
Iron Chelating Agents