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MetfOrmin BenefIts Lower Extremities With Intermittent Claudication

NCT05132439 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-21

No results posted yet for this study

Summary

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.

Conditions

  • Intermittent Claudication

Interventions

DRUG

Metformin ER

Oral medication typically used for Type 2 diabetes with presumed anti-inflammatory properties

DRUG

placebo

Matched to active study drug

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • Northwestern University

    collaborator OTHER

  • San Francisco Veterans Affairs Medical Center

    collaborator FED

  • VA Office of Research and Development

    lead FED

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2027-02-28
Completion
2032-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05132439 on ClinicalTrials.gov