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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.
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.
Diabetes Diabetes Foot Ulcer Disease (DFUD)
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:
2025 Protocol article in https://pubmed.ncbi.nlm.nih.gov/40186438/ (added 06/10/2025)
You can take part if:
Current inclusion criteria as of 06/10/2025:
1. Males and Females aged >= 18 years
2. Diagnosed with T2D
3. Current or previous DFUD (defined as diagnosed with DFUD in the previous 5 years)
4. Ability to speak and read English or have a willing proxy who speaks and reads English
5. Participant is able (in the Investigators opinion) and willing to fulfil all the study requirements
6. Currently not taking part in a CTIMP or any other disease management or lifestyle-related intervention trial
At the baseline visit, physical activity screening will be undertaken to assess safety considerations as a precaution prior to physical activity as part of the intervention. The participant may be excluded from the physical activity part of the intervention, but not the remaining intervention elements. Participants with both vascular and neuropathic ulcers
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.
Mrs
Tolu
Onuwe
+44 (0)756394005
tyo2@leicester.ac.uk
Dr
Patrick
Highton
-
MiFoot@uhl-tr.nhs.uk
Prof
Kamlesh
Khunti
-
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).
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 55056
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
