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Reducing the impact of diabetic foot ulcers (REDUCE): study protocol for an effectiveness and cost-effectiveness randomised controlled trial with embedded process evaluation

Natasha Mitchell, Kavita Vedhara, Kieran Ayling Orcid Logo, Alex Mitchell Orcid Logo, Christina Sheehan, Katherine Cullen Orcid Logo, Ruth Hart, Azeezat Adenike Okanlawon Orcid Logo, Catherine Arundel, Katherine Bradbury, Debbie Brewin, Trudie Chalder, Nicky Cullum Orcid Logo, Colin Dayan, Grazziela Figueredo, Deborah Fitzsimmons Orcid Logo, Catherine Hewitt, Glen Howard, Julia Lawton, Chris Metcalfe Orcid Logo, David Torgerson, Judith Watson Orcid Logo, Kirsty Winkley, Lucy Yardley, Frances Game Orcid Logo

BMJ Open, Volume: 16, Issue: 5, Start page: e118771

Swansea University Authors: Katherine Cullen Orcid Logo, Deborah Fitzsimmons Orcid Logo

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DOI (Published version): 10.1136/bmjopen-2026-118771

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 (RE...

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Published in: BMJ Open
ISSN: 2044-6055
Published: BMJ Publishing Group Ltd. 2026
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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. 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spelling 2026-06-19T14:44:52.4369300 v2 72131 2026-06-19 Reducing the impact of diabetic foot ulcers (REDUCE): study protocol for an effectiveness and cost-effectiveness randomised controlled trial with embedded process evaluation 9ddf9fac6330356b51fbb9f38fd6081f 0000-0002-3704-4598 Katherine Cullen Katherine Cullen true false e900d99a0977beccf607233b10c66b43 0000-0002-7286-8410 Deborah Fitzsimmons Deborah Fitzsimmons true false 2026-06-19 HSOC 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. Journal Article BMJ Open 16 5 e118771 BMJ Publishing Group Ltd. 2044-6055 24 5 2026 2026-05-24 10.1136/bmjopen-2026-118771 Protocol COLLEGE NANME Health and Social Care School COLLEGE CODE HSOC Swansea University Another institution paid the OA fee This work was supported by the National Institute for Health and Care Research (NIHR) under its Programme Grant for Applied Research (PGfAR) (Reference: RP-PG-0618-20001) and NIHR Efficacy and Mechanism Evaluation (EME) (Reference: NIHR154807) funding streams. 2026-06-19T14:44:52.4369300 2026-06-19T14:34:39.5696952 Faculty of Medicine, Health and Life Sciences School of Health and Social Care - Public Health Natasha Mitchell 1 Kavita Vedhara 2 Kieran Ayling 0000-0003-1766-8800 3 Alex Mitchell 0000-0001-9311-2092 4 Christina Sheehan 5 Katherine Cullen 0000-0002-3704-4598 6 Ruth Hart 7 Azeezat Adenike Okanlawon 0009-0002-5839-3292 8 Catherine Arundel 9 Katherine Bradbury 10 Debbie Brewin 11 Trudie Chalder 12 Nicky Cullum 0000-0003-2631-123X 13 Colin Dayan 14 Grazziela Figueredo 15 Deborah Fitzsimmons 0000-0002-7286-8410 16 Catherine Hewitt 17 Glen Howard 18 Julia Lawton 19 Chris Metcalfe 0000-0001-8318-8907 20 David Torgerson 21 Judith Watson 0000-0003-0694-3854 22 Kirsty Winkley 23 Lucy Yardley 24 Frances Game 0000-0002-5294-4789 25 72131__37017__79751872ff2349509ffc7a68905a92aa.pdf 72131.VOR.pdf 2026-06-19T14:42:01.4036506 Output 748424 application/pdf Version of Record true © Author(s) (or their employer(s)) 2026. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license. true eng https://creativecommons.org/licenses/by/4.0/
title Reducing the impact of diabetic foot ulcers (REDUCE): study protocol for an effectiveness and cost-effectiveness randomised controlled trial with embedded process evaluation
spellingShingle Reducing the impact of diabetic foot ulcers (REDUCE): study protocol for an effectiveness and cost-effectiveness randomised controlled trial with embedded process evaluation
Katherine Cullen
Deborah Fitzsimmons
title_short Reducing the impact of diabetic foot ulcers (REDUCE): study protocol for an effectiveness and cost-effectiveness randomised controlled trial with embedded process evaluation
title_full Reducing the impact of diabetic foot ulcers (REDUCE): study protocol for an effectiveness and cost-effectiveness randomised controlled trial with embedded process evaluation
title_fullStr Reducing the impact of diabetic foot ulcers (REDUCE): study protocol for an effectiveness and cost-effectiveness randomised controlled trial with embedded process evaluation
title_full_unstemmed Reducing the impact of diabetic foot ulcers (REDUCE): study protocol for an effectiveness and cost-effectiveness randomised controlled trial with embedded process evaluation
title_sort Reducing the impact of diabetic foot ulcers (REDUCE): study protocol for an effectiveness and cost-effectiveness randomised controlled trial with embedded process evaluation
author_id_str_mv 9ddf9fac6330356b51fbb9f38fd6081f
e900d99a0977beccf607233b10c66b43
author_id_fullname_str_mv 9ddf9fac6330356b51fbb9f38fd6081f_***_Katherine Cullen
e900d99a0977beccf607233b10c66b43_***_Deborah Fitzsimmons
author Katherine Cullen
Deborah Fitzsimmons
author2 Natasha Mitchell
Kavita Vedhara
Kieran Ayling
Alex Mitchell
Christina Sheehan
Katherine Cullen
Ruth Hart
Azeezat Adenike Okanlawon
Catherine Arundel
Katherine Bradbury
Debbie Brewin
Trudie Chalder
Nicky Cullum
Colin Dayan
Grazziela Figueredo
Deborah Fitzsimmons
Catherine Hewitt
Glen Howard
Julia Lawton
Chris Metcalfe
David Torgerson
Judith Watson
Kirsty Winkley
Lucy Yardley
Frances Game
format Journal article
container_title BMJ Open
container_volume 16
container_issue 5
container_start_page e118771
publishDate 2026
institution Swansea University
issn 2044-6055
doi_str_mv 10.1136/bmjopen-2026-118771
publisher BMJ Publishing Group Ltd.
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str School of Health and Social Care - Public Health{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}School of Health and Social Care - Public Health
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description 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.
published_date 2026-05-24T06:03:14Z
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score 11.109323

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