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

Primary Purpose

Critical Limb Ischemia, Peripheral Arterial Disease

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
disodium EDTA
Sponsored by
Mt. Sinai Medical Center, Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critical Limb Ischemia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open label EDTA chelation

Arm Description

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.

Outcomes

Primary Outcome Measures

Improvement in vascular flow parameters
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.
Wound Evaluation
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.
Peripheral Artery Questionnaire
The severity of PAD will be assessed at baseline, 20th and 40th infusions, with a Peripheral Arterial Questionnaire

Secondary Outcome Measures

Full Information

First Posted
January 31, 2018
Last Updated
June 6, 2019
Sponsor
Mt. Sinai Medical Center, Miami
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1. Study Identification

Unique Protocol Identification Number
NCT03424746
Brief Title
Chelation Therapy in Diabetic Patients With Critical Limb Ischemia
Acronym
TACT-PAD
Official Title
Pilot Trial of Limb Preservation Using Chelation Therapy in Diabetic Patients With Critical Limb Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
February 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mt. Sinai Medical Center, Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Pilot Trial Using Chelation Therapy for Limb Preservation in Diabetic Patients with Critical Limb Ischemia.
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: 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. Co-primary severity endpoint: Changes in pain scores, quality of life, wound severity, segmental lower extremity pressures and endothelial function. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia, Peripheral Arterial Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open label EDTA chelation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
disodium EDTA
Other Intervention Name(s)
chelation therapy
Intervention Description
Open-label study of TACT-formula, EDTA-based chelation therapy + commercially available TACT oral multi vitamins, delivering 40-50 infusions over 1 year.
Primary Outcome Measure Information:
Title
Improvement in vascular flow parameters
Description
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.
Time Frame
1 year
Title
Wound Evaluation
Description
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.
Time Frame
1 Year
Title
Peripheral Artery Questionnaire
Description
The severity of PAD will be assessed at baseline, 20th and 40th infusions, with a Peripheral Arterial Questionnaire
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gervasio Lamas, MD
Organizational Affiliation
Mount Sinai Medical Center of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Chelation Therapy in Diabetic Patients With Critical Limb Ischemia

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