QRC-PVD Clinical Trial - Metformin for Treating Peripheral Artery Disease-Related Walking Impairment (MERIT)

Peripheral Artery Disease (PAD) is a blockage and narrowing of arteries which leads to poor circulation in the legs. This reduces the ability of patients to undertake walking ability which reduces quality of life. There are no current effective treatments to manage PAD other than surgery. Surgery is the most common way to improve circulation however it is expensive and can have complications.

A number of research studies suggest a drug called Metformin may improve patients' physical activity. The drug is approved by the Australian Therapeutics Goods Administration and is well tolerated and safe for participants who do not have diabetes. Research suggests that Metformin may:

Encourage new blood vessels to form in the legs
Improve muscle function, and
Improve pain tolerance.

Recruitment Status	Currently recruiting
Sites Recruiting	Sites - The Townsville Hospital, Queensland; Royal Brisbane and Women's Hospital, Queensland
Ethics Approval	Human Research Ethics Approval HERC/18/QTHS/159

What's involved

Participants will be given medications to take however, half of the participants will be taking the real medication (metformin) and half will be taking a dummy medication (placebo). Neither you nor the researchers will know which one you’re taking. The aim of the study will be to see whether there is a change in walking distance after six months of taking the medication.

Taking part in this study will involve completing questionnaires, a physical assessment including physical tests, as well as blood sampling. There will be no costs associated with your participation in the research and this is not a paid research activity.

What you can expect

Initial visit	Health check-up: 6 minute walking test Blood pressure test of your legs Activity monitor fitted Blood test and collection	1-2 hours
Second visit	Removal of activity monitor and questionnaires. Medication is dispensed. Start taking medication.	1-2 hours
Week 1	Phone call with research team	10-15 minutes
Week 2	Phone call with research team	10-15 minutes
Week 3	Phone call with research team	10-15 minutes
Week 4	Phone call with research team	10-15 minutes
Week 5	Phone call with research team	10-15 minutes
Week 6	Phone call with research team	10-15 minutes
Week 10	Phone call with research team	10-15 minutes
Week 20	Phone call with research team	10-15 minutes
Week 30	Health check-up: 6 minute walking test Blood pressure test of your legs Activity monitor fitted Bood test and collection	1-2 hours
Week 31	Removal of activity monitor and questionnaires. Medication is ceased.	1-2 hours

How to participate

Participant Information Flyer and Consent Forms

Get Involved

Information for Participants

Participant Sign-up Form