MetfOrmin BenefIts Lower Extremities With Intermittent Claudication

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
VA Office of Research and Development
Study ID
NCT05132439
Phase
PHASE3
Status
Recruiting
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Conditions

  • Intermittent Claudication

Eligibility Criteria

Sex
ALL
Age
35 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin ER — DRUG
    Oral medication typically used for Type 2 diabetes with presumed anti-inflammatory properties
  • placebo — DRUG
    Matched to active study drug

Study Details

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.

Key Dates

Start date
Mar 1, 2022
Status verified
Apr 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2032

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Metformin ER 1000mg
    daily by mouth
  • Placebo Comparator: Matching placebo
    daily by mouth

Primary Outcome Measure

Maximal Walking distance on the 6 minute walk test [ Time Frame: 6 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PAPittsburghPennsylvania15240
Susan L Barr
[email protected]
412-360-2387
Samantha A Bonant, BS
[email protected]
(412) 360-3788
Edith I. Tzeng, MD (PRINCIPAL_INVESTIGATOR)

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VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA· Pittsburgh, PA

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