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Improve PAD PERformance With METformin | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

Improve PAD PERformance With METformin

Improve PAD Performance With Metformin: The PERMET Trial

NCT03054519•Northwestern University

Summary

The PERMET trial will determine whether metformin daily for six months improves six-minute walk performance in individuals with peripheral artery disease compared to placebo.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All participants will have PAD. PAD will be defined as follows:
•First, an ankle brachial index (ABI) \<=0.90 at the baseline study visit is an inclusion criterion for PAD.
•Second, potential participants who have an ABI \> 0.90 but ≤ 1.00 and experience a 20% or higher drop in ABI after heel-rise exercise will be eligible.
•Third, potential participants with an ABI \> 0.90 who have vascular lab evidence of PAD or angiographic evidence of PAD who have ischemic symptoms during the six-minute walk and/or treadmill exercise stress test will be eligible.
•Fourth, potential participants with a history of lower extremity revascularization who do not meet the criterion above and have an ABI \> 0.90 with a 20% or higher drop in ABI after heel-rise exercise will be eligible.

Exclusion Criteria

•Above- or below-knee amputation.
•Critical limb ischemia.
•Wheelchair-bound or requiring a walker to ambulate.
•Walking is limited by a symptom other than PAD.
•Current foot ulcer on bottom of foot.
•Diabetes mellitus defined as one or more of a) patient report of physician diagnosed diabetes mellitus, b) use of one or more diabetes medications, c) two baseline hemoglobinA1C values of \>6.5, d) two fasting glucose values \>126 mg/dl. \[NOTE: the second fasting glucose value and hemoglobin A1C values will be at the discretion of the principal investigator. For example, if the first glucose value is \>300 or the first A1C value is \>6.9, then investigators may decide not to repeat the value.\]
•Chronic kidney disease defined as GFR \<=45. \[NOTE: if GFR is 40-44, investigator discretion will be used to determine if a repeat test may be performed. If the second GFR value is \>45, the participant may be included.\]
•Chronic liver disease defined as two or more hepatic function tests \>=2.0 times the upper limit of normal. \[NOTE: participants who meet this criterion may undergo a re-test of hepatic function tests to determine whether initially elevated hepatic enzymes represented a transient or spurious phenomenon.\]
•Failure to successfully complete the 2-week study run-in, defined as unable to tolerate metformin and/or failing to take the medication daily for 10 or more days in the two-week period.
•Planned lower extremity revascularization, orthopedic surgery, or other major surgery during the next six months.
+10 more criteria

Locations (5)

University of Florida

Gainesville, Florida, United States

Northwestern University

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Tulane University

New Orleans, Louisiana, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Key Dates

Start Date

May 23, 2017

Primary Completion Date

August 20, 2025

Completion Date

November 1, 2025

Last Updated

August 26, 2025

Enrollment

203

ACTUAL participants

Conditions

Peripheral Artery Disease

Interventions

Metformin

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Improve PAD PERformance With METformin

Inclusion Criteria

Exclusion Criteria

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