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:
| 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:
| 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
Register your interest in participating in this study.