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REDUCE Pilot Trial - Reducing the impact of diabetic foot ulcers

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. The evidence for treatments to encourage healing is also unclear. Patient education is recommended to prevent ulcers, but education alone does not work. Research suggests that people’s thoughts, feelings and behaviours can affect the risk of getting diabetic foot ulcers and how they heal.

A treatment called REDUCE has been developed to help people change these ‘risk factors’ in order to lower their chances of getting DFUs, and encourage faster healing when they occur. REDUCE has two parts. The first helps people start the process of changing these risk factors. The second supports people to maintain these changes.

Before running a large study to look at whether REDUCE works and how much it costs, we want to run a smaller study (a pilot study) with approximately 20 patients. This pilot study will iron out any problems that may occur in how we conduct the larger study. A nested qualitative study will be conducted with patients and the healthcare professionals (HCPs), to examine how we deliver REDUCE.

For this study, instead of randomly allocating patients to REDUCE or the usual care groups equally, for every 3 people we recruit, 2 will be allocated to REDUCE and 1 person to usual care. This will ensure there will be enough people in this small study who can tell us about their experiences of receiving REDUCE.

The study is being run by the University Hospitals of Derby and Burton NHS Foundation Trust and the University of York, with funding from the National Institute for Health Research Programme Grant for Applied Research (Ref: RP-PG0618-20001). Professor Frances Game is the Chief Investigator.

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Funding

Funder(s)

NIHR Programme Grant for Applied Research
Start Date January 2020
End Date December 2025

Members

YTU Team

External Members

  • Professor Fran Game - University Hospitals of Derby and Burton NHS Foundation Trust
  • Professor Kavita Vedhara - University of Nottingham
  • Dr Katherine Bradbury - University of Southampton
  • Professor Lucy Yardley - University of Southampton
  • Professor Trudie Chalder - King's College London
  • Dr Kirsty Winkley - King's College London
  • Professor Julia Lawton - Usher Institute of Population Health Sciences and Informatics
  • Dr Ruth Hart - Usher Institute of Population Health Sciences and Informatics
  • Professor Deborah Fitzsimmons - Swansea University
  • Professor Chris Metcalfe - University of Bristol
  • Professor Colin Dayan - Cardiff University