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)

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Abstract
Background: In the United Kingdom, the prevalence of diabetes‐related foot ulcer disease (DFUD) is 6.3%, and cardiovascular disease (CVD) is the leading cause of mortality in people with DFUD. This study aims to evaluate the effectiveness of a multifactorial intervention to reduce CVD events and mortality in adults with type 2 diabetes (T2D) and DFUD. Methods: The MiFoot study is a multi‐centre, pragmatic randomised controlled trial to test intervention effectiveness and cost‐effectiveness compared to usual care that will include an internal feasibility study and a process evaluation. English‐speaking adults (≥18 years; n = 392) with T2D and current/previous (within 5 years) DFUD will be recruited from multiple sites across the United Kingdom and randomised 1:1 to intervention (MiFoot multifactorial intervention plus usual care) or control (usual care), with data collected at baseline, 12‐ and 24‐month follow‐up. The MiFoot intervention comprises an individualised assessment with a healthcare practitioner to optimise treatment and assess the suitability of physical activity participation; group‐based disease self management education and physical activity sessions; and a digital‐based programme, consisting of cohort‐relevant topics, physical activity guidance and peer support functionality. The primary outcome will be extended major adverse cardiovascular events (MACE, i.e. myocardial infarction, stroke, cardiovascular death, peripheral arterial bypass, coronary artery bypass, coronary angioplasty or peripheral artery angioplasty) at 24 months. DISCUSSION: This study will provide evidence on the feasibility and clinical effectiveness, and cost‐effectiveness of a multifactorial intervention to prevent or slow the progression of CVD‐related complications in the extremely high‐risk population with T2D and DFUD.

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