MiFoot – reducing heart disease risk in those with a history of diabetic foot ulcers
- Conditions
- DiabetesNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN13413505
- Lead Sponsor
- niversity of Leicester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 392
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
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 will be eligible.
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 involvement
4. Planned major surgery
5. Requirement for renal replacement therapy
6. Current pregnancy, or actively trying to conceive
7. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Extended MACE (myocardial infarction, stroke, cardiovascular death, peripheral arterial bypass, coronary artery bypass, coronary angioplasty, or peripheral artery angioplasty) by 2 years, measured at 0, 12 and 24 months via data extraction from routine healthcare records
- Secondary Outcome Measures
Name Time Method