A multifactorial intervention to improve cardiovascular outcomes in adults with type 2 diabetes and current or previous diabetic foot ulcer disease: Protocol for a multi‐centre randomised control trial ( MiFoot study)
Study context
- Population
- English-speaking adults (≥18 years) with T2D and current/previous (within 5 years) DFUD, multiple UK sitesplanned
- Participants
- 392 adults
- Planned comparison
- MiFoot multifactorial intervention plus usual care vs usual care
- Primary endpoint
- Extended major adverse cardiovascular events (MACE): MI, stroke, cardiovascular death, peripheral arterial bypass, coronary artery bypass, coronary angioplasty or peripheral artery angioplasty
- Follow-up
- 24 months
Methodological detailsmulti-centre, pragmatic, internal feasibility study, process evaluation, cost-effectiveness, Data collected at baseline, 12- and 24-month follow-up
- Multi-centre
- Pragmatic
- Internal feasibility study
- Process evaluation
- Cost-effectiveness
- Data collected at baseline, 12- and 24-month follow-up
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
A multifactorial intervention to improve cardiovascular outcomes in adults with type 2 diabetes and current or previous diabetic foot ulcer disease: Protocol for a multi‐centre randomised control trial ( MiFoot study). Diabet Med. Published 5 April 2025. doi:10.
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