{
  "abstract": "Introduction Diabetic foot ulceration represents a prevalent, persistent and resource-intensive complication of diabetes. These ulcers are slow to heal, prone to recurrence and impose a substantial burden on both patients and healthcare providers. The reducing the impact of diabetic foot ulcers (REDUCE) intervention has been designed as a multifaceted approach targeting psychological and behavioural determinants linked to diabetic foot ulcer (DFU) outcomes. Following a successful pilot trial, the REDUCE trial has been designed as a pragmatic, multicentre randomised trial to compare the effectiveness and cost-effectiveness of the REDUCE intervention plus usual care versus usual care alone in reducing recurrence in people with healed DFUs. Additionally, there is an embedded process evaluation and two sub-studies which will be carried out alongside the main trial.Methods and analysis Adults over 18 years of age, with a recently healed DFU and two lower limbs, will be identified from around 30 specialist multidisciplinary diabetic foot clinics at participating National Health Service Trusts in the UK. Patients with active Charcot neuro-osteoarthropathy, active DFU or ulcers healed for more than 12 weeks will be excluded. We will aim to recruit 544 participants (1:1 randomisation). The primary outcome for this trial will be total ulcer-free days with limbs intact (ie, without amputation) between randomisation and the end of follow-up (18 months post-randomisation). Secondary outcomes include time to re-ulceration, total number of ulcers, amputation, quality of life (EQ-5D-5L), Patient Health Questionnaire-9, Nottingham Assessment of Functional Footcare, ICEpop capability measure for adults and resource use. As part of the process evaluation, up to 20 REDUCE intervention patient-participants will be interviewed, and the healthcare professionals delivering the intervention will also be interviewed. An assessment of intervention fidelity will also be carried out.Ethics and dissemination Ethics approval was granted by Wales 3 Research Ethics Committee (REC reference 22/WA/0053) on 16 March 2022. The findings will be presented at relevant conferences and disseminated via peer-reviewed research publications and to relevant stakeholders.Trial registration number ISRCTN15570706.",
  "authors": [
    {
      "affiliations": [
        "Department of Health Sciences, Alcuin Research Resource Centre, Heslington, University of York, York, UK"
      ],
      "name": "Natasha Mitchell"
    },
    {
      "affiliations": [
        "School of Psychology, Cardiff University, Cardiff, UK"
      ],
      "name": "Kavita Vedhara"
    },
    {
      "affiliations": [
        "Centre for Academic Primary Care, University of Nottingham, Nottingham, UK"
      ],
      "name": "Kieran Ayling"
    },
    {
      "affiliations": [
        "Department of Health Sciences, Alcuin Research Resource Centre, Heslington, University of York, York, UK"
      ],
      "name": "Alex Mitchell"
    },
    {
      "affiliations": [
        "Centre for Academic Primary Care, University of Nottingham, Nottingham, UK"
      ],
      "name": "Christina Sheehan"
    },
    {
      "affiliations": [
        "Psychology, Swansea University, Swansea, UK"
      ],
      "name": "Katherine Cullen"
    },
    {
      "affiliations": [
        "The University of Edinburgh Usher Institute of Population Health Sciences and Informatics, Edinburgh, Scotland, UK"
      ],
      "name": "Ruth Hart"
    },
    {
      "affiliations": [
        "Department of Health Sciences, Alcuin Research Resource Centre, Heslington, University of York, York, UK"
      ],
      "name": "Azeezat Adenike Okanlawon"
    },
    {
      "affiliations": [
        "Department of Health Sciences, Alcuin Research Resource Centre, Heslington, University of York, York, UK"
      ],
      "name": "Catherine Arundel"
    },
    {
      "affiliations": [
        "Psychology, University of Southampton, Southampton, England, UK"
      ],
      "name": "Katherine Bradbury"
    },
    {
      "affiliations": [
        "King’s College London, London, England, UK"
      ],
      "name": "Debbie Brewin"
    },
    {
      "affiliations": [
        "Department of Psychological Medicine, King’s College London, London, UK"
      ],
      "name": "Trudie Chalder"
    },
    {
      "affiliations": [
        "Division of Nursing, Midwifery and Social Work, The University of Manchester, Manchester, UK"
      ],
      "name": "Nicky Cullum"
    },
    {
      "affiliations": [
        "School of Medicine, Cardiff University, Cardiff, UK"
      ],
      "name": "Colin Dayan"
    },
    {
      "affiliations": [
        "Lifespan and Population Health, University of Nottingham, Nottingham, UK"
      ],
      "name": "Grazziela Figueredo"
    },
    {
      "affiliations": [
        "Swansea Centre for Health Economics, Swansea University, Swansea, UK"
      ],
      "name": "Deborah Fitzsimmons"
    },
    {
      "affiliations": [
        "Department of Health Sciences, University of York, York, UK"
      ],
      "name": "Catherine Hewitt"
    },
    {
      "affiliations": [
        "Health Innovation East Midlands, Nottingham, UK"
      ],
      "name": "Glen Howard"
    },
    {
      "affiliations": [
        "The University of Edinburgh Usher Institute of Population Health Sciences and Informatics, Edinburgh, Scotland, UK"
      ],
      "name": "Julia Lawton"
    },
    {
      "affiliations": [
        "Bristol Medical School, University of Bristol, Bristol, UK"
      ],
      "name": "Chris Metcalfe"
    },
    {
      "affiliations": [
        "Department of Health Sciences, Alcuin Research Resource Centre, Heslington, University of York, York, UK"
      ],
      "name": "David Torgerson"
    },
    {
      "affiliations": [
        "Department of Health Sciences, Alcuin Research Resource Centre, Heslington, University of York, York, UK"
      ],
      "name": "Judith Watson"
    },
    {
      "affiliations": [
        "Care in Long-Term Conditions, Nursing, Midwifery and Palliative Care, King’s College London, London, UK"
      ],
      "name": "Kirsty Winkley"
    },
    {
      "affiliations": [
        "Psychology, University of Southampton, Southampton, UK"
      ],
      "name": "Lucy Yardley"
    },
    {
      "affiliations": [
        "University Hospitals of Derby and Burton NHS Foundation Trust, Derby, England, UK"
      ],
      "name": "Frances Game"
    }
  ],
  "title": "Reducing the impact of diabetic foot ulcers (REDUCE): study protocol for an effectiveness and cost-effectiveness randomised controlled trial with embedded process evaluation",
  "uid": "eeefb2b2-5628-5578-9953-cb15307902ba"
}