MiFoot RCT

  • Research type

    Research Study

  • Full title

    A Multifactorial Intervention to Improve Cardiovascular Outcomes in Adults with Type 2 Diabetes and Current or Previous Diabetes-related Foot Ulcers - randomised controlled trial (MiFoot RCT)

  • IRAS ID

    322098

  • Contact name

    Kamlesh Khunti

  • Contact email

    MiFoot@uhl-tr.nhs.uk

  • Sponsor organisation

    University of Leicester

  • Duration of Study in the UK

    3 years, 5 months, 31 days

  • Research summary

    Background to the research

    People with Type 2 diabetes and either a current or previous diabetes-related foot ulcer are often at high risk for future heart problems, such as heart attacks or strokes. This may be caused by different factors such as difficulty in being physically active, or managing their often complex condition. People might also find it more difficult to do every-day activities that are important to them, feel more anxious or depressed, and may need to use healthcare services more often. Healthcare for people with diabetes-related foot ulcers is usually focussed on treating the ulcer, and not preventing long-term heart problems.

    What is MiFoot RCT?

    The MiFoot RCT is a research study that will test a programme designed to improve heart health in people with diabetes and diabetes-related foot ulcers.

    MiFoot programme aims to help people to better manage their condition, receive the most up to date care and be more physically active.

    The MiFoot programme will include:
    • Group-based education and exercise sessions
    • One to one session with a health care professional
    • An online platform designed to support patients to live a healthy lifestyle

    We want to see whether the MiFoot programme can improve the health of people with current or previous diabetes-related foot ulcers, and if it is good value for money.

    What does the study involve?

    The study lasts 2 years, involves face-to-face visits to participants local hospital, the completion of questionnaires and the wearing of an activity monitor to measure your physical activity.

    Who can take part?

    Eligible participants must meet all the inclusion criteria and not meet any of the exclusion criteria.

  • REC name

    North East - York Research Ethics Committee

  • REC reference

    23/NE/0136

  • Date of REC Opinion

    14 Jul 2023

  • REC opinion

    Favourable Opinion