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Metformin for Intermittent Claudication (MOBILE IC Trial)
MOBILE IC Trial Summary
This trial is testing whether Metformin can improve the symptoms of peripheral artery disease and intermittent claudication, which are caused by blockages in the peripheral arteries.
MOBILE IC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMOBILE IC Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 1 trial • 68 Patients • NCT02084082MOBILE IC Trial Design
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Who is running the clinical trial?
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- I have diabetes or my blood sugar levels have been high in the past 6 months.I cannot swallow pills that are not crushed.I am scheduled for a major surgery or hospital stay within the next year.I have severe leg pain or non-healing wounds due to poor blood flow.I am currently on metformin or was on it within the last 6 months.You are planning to have a test using iodine contrast dye within 6 months of the study start date.I have a health condition other than PAD that affects my ability to walk.My kidney function is low, needing dialysis or has an eGFR under 45.I can walk more than 50 meters but not over 400 meters without severe pain, using only a cane if needed.I've been on stable heart and blood vessel health treatment for over 3 months, including lifestyle changes.I am a veteran aged between 35 and 89.I have had liver failure or currently have it.I have been diagnosed with PAD, confirmed by tests within the last 6 months.I experience leg pain when I walk.I am not pregnant or breastfeeding.I have not had major surgery or leg artery surgery in the last 3 months.I have had an amputation above or below the knee.My doctor has tried to give me the best treatment I can handle before joining this trial.
- Group 1: Matching placebo
- Group 2: Metformin ER 1000mg
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any detrimental effects to taking Metformin ER?
"Metformin ER is a Phase 3 trial medication, meaning that there is both efficacy and safety data available. Power rates the safety of this drug as a 3."
What other scientific papers have been published about Metformin ER?
"Out of the 45 Phase 3 trials for Metformin ER, 180 are currently active. Although Pittsburgh, Pennsylvania has a high concentration of these studies, there are actually 1952 locations conducting research on this medication."
How many individuals are being given this medication as part of the research trial?
"That is correct, the online information indicates that this study is looking for volunteers. The trial was initially posted on March 1st, 2022 and updated most recently on July 11th, 2022. They are hoping to enroll 200 patients from a single site."
Are people of all ages being accepted for this study?
"The ages of eligible candidates for this clinical trial range from 35 years old to 89 years young."
For what health issues is Metformin ER most commonly prescribed?
"Metformin ER is mostly used to help people exercise, but it can also be employed as a treatment for type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."
Are we able to sign up for this research project?
"The trial is presently recruiting patients, with the original posting date on clinicaltrials.gov being March 1st, 2022 and the most recent update occurring on July 11th of the same year."
What are the entrance requirements for this clinical trial?
"Intermittent claudication and an age between 35 and 89 are the inclusion criteria for this trial. The goal is to have 200 individuals enrolled in the study."
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