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NCT05132439 · ClinicalTrials.gov registry record · Phase 3
MetfOrmin BenefIts Lower Extremities With Intermittent Claudication
A Phase 3 study of Intermittent Claudication, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT05132439 is a Phase 3 study of Intermittent Claudication that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 200 participants, roughly in line with the 198-participant average among 11 other Intermittent Claudication trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT05132439, a Phase 3 study of Intermittent Claudication, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DRUG placebo
- DRUG Metformin ER
Study Locations (1)
Pennsylvania
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-03-01 |
| Est. Completion | 2031-02-28 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05132439
The ClinicalTrials.gov registry entry for NCT05132439 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 198-participant average among 11 other Intermittent Claudication trials with a reported enrollment target. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Intermittent Claudication appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT05132439 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05132439 about?
NCT05132439 is a clinical study titled "MetfOrmin BenefIts Lower Extremities With Intermittent Claudication". 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 activ...
What is the current status of trial NCT05132439?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2022-03-01. Estimated completion is 2031-02-28.
What conditions does trial NCT05132439 study?
This clinical trial studies the following conditions: Intermittent Claudication.
What interventions are being tested in trial NCT05132439?
The interventions under investigation include: placebo (DRUG), Metformin ER (DRUG).
Who is sponsoring clinical trial NCT05132439?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05132439 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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