Evidence map›Paper›PMID 40186438›Full record

ArticleDiabetic medicine : a journal of the British Diabetic Association2025

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 and 13 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetic medicine : a journal of the British Diabetic Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Banting memorial lecture 2025: Aligning clinical practice, policy and research.Diabetic medicine : a journal of the British Diabetic Association · 2026
    Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Tolu OnuweDiabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK.ORCID https://orcid.org/0000-0003-3716-4925
Patrick J HightonDiabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK.ORCID https://orcid.org/0000-0002-0410-5788
David BatchelorPatient and Public Involvement and Engagement Representative, Leicester, UK.
Alan BrennanSchool of Medicine and Population Health, University of Sheffield, Sheffield, UK.
Molly CabaDiabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK.
Melanie J DaviesDiabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK.ORCID https://orcid.org/0000-0002-9987-9371
Mark P FunnellDiabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK.
Frances GameDepartment of Research and Development, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK.
Clare L GilliesDiabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK.
Agnieszka GlabLeicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester General Hospital, Leicester, UK.
Laura J GrayNational Institute for Health and Care Research Applied Research Collaboration East Midlands, Leicester, UK.ORCID https://orcid.org/0000-0002-9284-9321
Edward GreggSchool of Population Health, RCSI University of Medicine and Health Sciences, Dublin, Ireland.
Michelle HadjiconstantinouDiabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK.
Vicky HallLeicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester General Hospital, Leicester, UK.
Vicki JohnsonLeicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester General Hospital, Leicester, UK.
John R PetrieSchool of Health and Wellbeing, College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.ORCID https://orcid.org/0000-0002-4894-9819
Dan PollardSchool of Medicine and Population Health, University of Sheffield, Sheffield, UK.ORCID https://orcid.org/0000-0001-5630-0115
Hannah RowntreeLeicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester General Hospital, Leicester, UK.
Solomon TesfayeDiabetes Research Unit, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
Jonathan ValabhjiDepartment of Metabolism, Digestion and Reproduction, Faculty of Medicine, Chelsea and Westminster Hospital Campus, Imperial College London, London, UK.
David WebbDiabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK.
Francesco ZaccardiLeicester Real World Evidence Unit, Leicester Diabetes Centre, University of Leicester, Leicester, UK.
Kamlesh KhuntiDiabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK.ORCID https://orcid.org/0000-0003-2343-7099

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn 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.

methodsThe 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.

Indexed as

Cardiovascular DiseasesDiabetes Mellitus, Type 2Diabetic FootAdultCost-Benefit AnalysisFeasibility StudiesFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicTreatment OutcomeUnited Kingdomcardiovascular diseasediabetes‐related foot ulcer diseasedigital‐based programmelifestylemortalityphysical activityself management education programme

Identifiers

PMID40186438
PMCPMC12080985

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.