Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Kamlesh Khunti
-
MiFoot@uhl-tr.nhs.uk


Dr Patrick Highton
-
MiFoot@uhl-tr.nhs.uk


Mrs Tolu Onuwe
+44 (0)756394005
tyo2@leicester.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - MiFoot – reducing heart disease risk in those with a history of diabetic foot ulcers

MiFoot – reducing heart disease risk in those with a history of diabetic foot ulcers

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Diabetes


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Nov 2023 31 Mar 2024

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.


Adults over 18 years, with type 2 diabetes and current or previous diabetes-related foot ulcers.

You can take part if:



You may not be able to take part if:


1. Diagnosed with other forms of diabetes (e.g., type 1 diabetes, monogenic diabetes (MODY), gestational diabetes or latent autoimmune diabetes in adults (LADA)2. Other, non-diabetic forms of ulceration (e.g., venous)3. Serious illness or event with life-expectancy < 1 year or other significant illness which, in the opinion of a study clinician, precludes involvement4. Planned major surgery5. Requirement for renal replacement therapy6. Current pregnancy, or actively trying to conceive7. Unwilling or unable to give informed consent to participate in the study 8. Current participation in a CTIMP or any other disease management or lifestyle-related intervention study (as determined by study investigator)9. Unable to understand or read English

Inability to participate in physical activity part of the intervention will not preclude inclusion in the study or the rest of the intervention, in order to represent the real-world situation. We will collect data concerning this as part of the process evaluation (section 5.2.2). The intervention will be delivered in English language and as such any participants who do not speak or read English to a sufficient standard will be excluded from the study. Every effort will be made to support participants with minimal English proficiency to participate.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Northern General Hospital
    Sheffield Teaching Hospitals NHS Foundation Trust Herries Road
    Sheffield
    S5 7AU
  • Leicester Royal Infirmary
    Infirmary Square
    Leicester
    LE1 5WW
  • Imperial College Healthcare NHS Trust
    The Bays St Marys Hospital South Wharf Road
    London
    W2 1BL
  • Royal Derby Hospital
    University Hospitals of Derby and Burton NHS Foundation Trust Uttoxeter Road
    Derby
    DE22 3NE
  • NHS National Services Scotland
    Gyle Square 1 South Gyle Square
    Edinburgh
    EH12 9EB
  • NIHR CRN: North West London
    Imperial College Healthcare NHS Trust Hammersmith Hospital Du Cane Road
    London
    W12 0HT
  • NIHR CRN: East Midlands
    Knighton Street Outpatients 1st Floor Leicester Royal Infirmary
    Leicester
    LE1 5WW
  • NIHR CRN: Yorkshire and Humber
    8 Beech Hill Road
    Sheffield
    S10 2SB

Taking part in this research study could potentially benefit other people with diabetes and diabetes-related foot ulcers by providing information on how best to organise and deliver care in order to improve heart health and reduce the risk of future heart problems. This is important as there has not been much research in this area. The results could lead to improved medical treatments and care in the future.
Although there are many benefits of physical activity, it can pose some risks, however it is anticipated that these will be minimal. For example, you may experience delayed onset muscle soreness. Physical activity carried out as part of the MiFoot programme will be light-moderate, which can equate to walking upstairs or completing housework; therefore, your risk would not be increased over and above their usual day to day activities.

Prof Kamlesh Khunti
-
MiFoot@uhl-tr.nhs.uk


Mrs Tolu Onuwe
+44 (0)756394005
tyo2@leicester.ac.uk


Dr Patrick Highton
-
MiFoot@uhl-tr.nhs.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Leicester and funded by NIHR Central Commissioning Facility (CCF).





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Read full details for Trial ID: ISRCTN13413505

Or CPMS 55056

Last updated 11 September 2024

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