Chelation Therapy in Diabetic Patients With Critical Limb Ischemia

NCT03424746 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 14-36-H-07
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Critical Limb Ischemia; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (3)

• 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.

  1 year

• 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.

  1 Year

• Peripheral Artery Questionnaire

  The severity of PAD will be assessed at baseline, 20th and 40th infusions, with a Peripheral Arterial Questionnaire

  1 Year

Study Arms (1)

Open label EDTA chelation

EXPERIMENTAL

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

Interventions

disodium EDTA DRUG

Open-label study of TACT-formula, EDTA-based chelation therapy + commercially available TACT oral multi vitamins, delivering 40-50 infusions over 1 year.

Also known as: chelation therapy

Open label EDTA chelation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mt. Sinai Medical Center, Miami: lead

Study Sites (1)

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

Interventions

Edetic Acid; Chelation Therapy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Drug Therapy; Therapeutics

Study Officials

• Gervasio Lamas, MD

  Mount Sinai Medical Center of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Medicine- Chief, Division of Cardiology

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 7, 2018
• Study Start: August 1, 2015
• Primary Completion: January 31, 2019
• Study Completion: February 18, 2019
• Last Updated: June 10, 2019

Record last verified: 2019-06

Locations

US (1)