Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Intermittent Claudication, sponsored by VA Office of Research and Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This validated measure of functional status in PAD and IC is highly reproducible and the ideal measure of real-life walking capacity
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 |
What NCT05132439 shows while recruiting
NCT05132439 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 198-participant average among 11 other Intermittent Claudication trials with a reported enrollment target.
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Intermittent Claudication
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05132439's enrollment target sits among peer trials
200 5th of 11 higher than 6 of 11 other Intermittent Claudication trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Intermittent Claudication trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Improving Mobility After Revascularization in Peripheral Artery Disease
RECRUITING · Phase 3
-
Response to Exercise and Nitric Oxide in PAD
RECRUITING · Phase 2
-
The Chocolate Touch Study
ACTIVE NOT RECRUITING · NA
-
A Phase 2 Study of the Effects of Sapropterin Dihydrochloride on Symptomatic Peripheral Arterial Disease
COMPLETED · Phase 2
-
Distributed Registry
COMPLETED
-
Efficacy and Safety of HMR1766 in Patients With Fontaine Stage II Peripheral Arterial Disease
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00107289 · 200 participants · Phase 2
Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
- NCT00109174 · 200 participants · NA
MRS Measurement of Glutamate and GABA Metabolism in Brain
- NCT00177268 · 200 participants
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
- NCT00493688 · 200 participants
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI