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.
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