MetfOrmin BenefIts Lower Extremities With Intermittent Claudication

Recruiting Phase 3 Interventional Study
Intermittent Claudication
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
35 – 89
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
VA Office of Research and Development · Federal
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About This Trial
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 i…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Male and Female Veteran \>35 \& \<89 * Symptoms of Intermittent claudication * 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 co…
Contacts

Edith I Tzeng, MD

(412) 360-1657

Edith.Tzeng@va.gov

CONTACT