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).
Tolu Onuwe, Patrick J Highton, David Batchelor, Alan Brennan, Molly Caba, Melanie J Davies, Mark P Funnell, Frances Game, Clare L Gillies, Agnieszka Glab, Laura J Gray, Edward Gregg, Michelle Hadjiconstantinou, Vicky Hall, Vicki Johnson, John R Petrie, Dan Pollard, Hannah Rowntree, Solomon Tesfaye, Jonathan Valabhji, David Webb, Francesco Zaccardi, Kamlesh Khunti
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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.
期刊介绍：
Diabetic Medicine, the official journal of Diabetes UK, is published monthly simultaneously, in print and online editions.
The journal publishes a range of key information on all clinical aspects of diabetes mellitus, ranging from human genetic studies through clinical physiology and trials to diabetes epidemiology. We do not publish original animal or cell culture studies unless they are part of a study of clinical diabetes involving humans. Categories of publication include research articles, reviews, editorials, commentaries, and correspondence. All material is peer-reviewed.
We aim to disseminate knowledge about diabetes research with the goal of improving the management of people with diabetes. The journal therefore seeks to provide a forum for the exchange of ideas between clinicians and researchers worldwide. Topics covered are of importance to all healthcare professionals working with people with diabetes, whether in primary care or specialist services.
Surplus generated from the sale of Diabetic Medicine is used by Diabetes UK to know diabetes better and fight diabetes more effectively on behalf of all people affected by and at risk of diabetes as well as their families and carers.”
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