RECRUITING

MetfOrmin BenefIts Lower Extremities With Intermittent Claudication

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Conditions

Intermittent ClaudicationPeripheral artery diseasemetforminanti-inflammatory agentsclinical trial protocolatherosclerosis

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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

Peripheral arterial disease (PAD) affects over 20% of aged adults and is very common among Veterans due significant tobacco use. PAD is due to the progressive blockage of peripheral arteries, predominantly to the legs, and results in intermittent claudication (IC) or recurrent muscle pain with activity secondary to insufficient blood supply. Those with PAD and IC experience a progressive decline in walking and poor quality of life. There is no effective medical treatment for PAD and IC. Metformin is a safe and effective treatment for Type 2 diabetes but it can also reduce inflammation, oxidative stress, and improve energy requirements as well as improve blood flow to the legs. Therefore, the investigators will test the ability of Metformin to improve overall functional status, reduce PAD progression, and reduce systemic inflammation in Veterans suffering from PAD and IC in a randomized, placebo controlled trial: Metformin BenefIts Lower Extremities with Intermittent Claudication (MOBILE IC) Trial. The success of this trial may identify a safe and effective treatment for PAD and IC.

Official Title

Metformin BenefIts Lower Extremities With Intermittent Claudication (MOBILE_IC)

Quick Facts

Study Start:2022-03-01
Study Completion:2031-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05132439

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:35 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and Female Veteran \>35 \& \<89
  2. * Symptoms of Intermittent claudication
  3. * Medically stable, optimal medical therapy (for \>3 months prior to randomization which includes - statin and anti-platelet therapy, blood pressure control, smoking cessation and physical activity counseling)
  4. * PAD as defined by ABI \<0.9 or \>0.9 with evidence of PAD as documented by pulse volume recordings (within 6 months prior to expected randomization date)
  5. * Maximum Walking Distance (MWD) on the 6-minute walk test (6MWT) of greater than or equal to 50 meters with onset of pain before or at 400 meters without the use of a walker (cane is acceptable; within 6 months of expected randomization date)
  1. * Diabetes (Type I or II) or Hemoglobin A1c\>6.5 (within 6 months of expected randomization)
  2. * Currently Taking metformin or have previously taken metformin (within 6 months of enrollment)
  3. * Medical condition that limit their ability to ambulate other than PAD (i.e., Angina, CHF, pulmonary disease requiring oxygen, malignancy requiring treatment, etc.)
  4. * Prior above or below knee amputation
  5. * Critical limb threatening ischemia (i.e., non-healing wounds or rest pain)
  6. * Planned hospital admission, major operation, or lower extremity revascularization to be completed (within 12 months after expected randomization date)
  7. * Prior major operation or lower extremity revascularization (within the 3 months before expected randomization)
  8. * Unable to complete quality of life testing due to Non-English Speaking and/or Dementia
  9. * Kidney disease - dialysis or eGFR\<45 (within 6 months of expected randomization date)\*
  10. * Planned iodinated contrasted study (within 6 months of expected randomization date)
  11. * Evidence current or history of hepatic failure
  12. * Women who are pregnant or breast feeding
  13. * Unable to swallow uncrushed pills
  14. * Investigator expects inclusion could cause harm to subject

Contacts and Locations

Study Contact

Edith I Tzeng, MD
CONTACT
(412) 360-1657
Edith.Tzeng@va.gov
Katherine M Reitz
CONTACT
(412) 688-6000
reitzkm2@upmc.edu

Principal Investigator

Edith I. Tzeng, MD
PRINCIPAL_INVESTIGATOR
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study Locations (Sites)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Edith I. Tzeng, MD, PRINCIPAL_INVESTIGATOR, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

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 Date2022-03-01
Study Completion Date2031-02-28

Study Record Updates

Study Start Date2022-03-01
Study Completion Date2031-02-28

Terms related to this study

Keywords Provided by Researchers

  • Peripheral artery disease
  • intermittent claudication
  • metformin
  • anti-inflammatory agents
  • clinical trial protocol
  • atherosclerosis

Additional Relevant MeSH Terms

  • Intermittent Claudication