REDUCE Trial: Reducing the impact of DFUs (RCT)
Research type
Research Study
Full title
Reducing the impact of diabetic foot ulcers (REDUCE): A effectiveness and cost-effectiveness Randomised Controlled Trial
IRAS ID
274384
Contact name
Frances Game
Contact email
Sponsor organisation
University Hospitals of Derby and Burton NHS Foundation Trust
ISRCTN Number
ISRCTN15570706
Duration of Study in the UK
3 years, 9 months, 28 days
Research summary
Background: Diabetic foot ulcers (DFUs) are poorly healing wounds below the ankle affecting 25% of people with diabetes. Less than half of people will be ulcer-free after 6 months of treatment, and the same number will experience another ulcer within a year.
Current treatments to prevent and heal ulcers do not work well. People’s thoughts, feelings and behaviours can affect the risk of getting DFUs and how they heal. We have developed a new way of helping people with diabetes who have had a foot ulcer previously, called ‘REDUCE’. The package includes 8 one hour sessions with a healthcare
professional (HCP), such as a diabetes nurse, and support through a website. The REDUCE training programme and trial procedures have been refined following the pilot.Aims: To investigate the effectiveness and cost-effectiveness of the REDUCE intervention compared with patients who receive usual care following their healed diabetic foot ulcers.
Method: 544 patients will be recruited to this study. Half will be randomly allocated to receive the REDUCE package and half to receive their usual care. Patients will be identified by their clinical care team or screening of clinic lists.
Outcomes: All participants will complete a questionnaire at the start of the study, 6 weeks, 3, 6 and 18 months. 20 REDUCE package participants will be interviewed at the start, 3 and 6 months later. HCPs will be interviewed during the study/after they have delivered all their REDUCE sessions; sessions will be recorded to check how closely they are following the delivery of the REDUCE programme. A participant’s use of NHS resources during their time in the study (e.g. new admissions to hospital, new foot ulcers) will be collected.
Public Involvement: The public involvement panel have been involved in the design and development of the study and the intervention. They continue to contribute to the study as we progress.
REC name
Wales REC 3
REC reference
22/WA/0053
Date of REC Opinion
16 Mar 2022
REC opinion
Favourable Opinion