Journal article 13 views 3 downloads
Reducing the impact of diabetic foot ulcers (REDUCE): study protocol for an effectiveness and cost-effectiveness randomised controlled trial with embedded process evaluation
,
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
BMJ Open, Volume: 16, Issue: 5, Start page: e118771
Swansea University Authors:
Katherine Cullen , Deborah Fitzsimmons
-
PDF | Version of Record
© 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.
Download (730.88KB)
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...
| Published in: | BMJ Open |
|---|---|
| ISSN: | 2044-6055 |
| Published: |
BMJ Publishing Group Ltd.
2026
|
| Online Access: |
Check full text
|
| URI: | https://cronfa.swan.ac.uk/Record/cronfa72131 |
| 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. |
|---|---|
| Item Description: |
Protocol |
| College: |
Faculty of Medicine, Health and Life Sciences |
| Funders: |
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. |
| Issue: |
5 |
| Start Page: |
e118771 |