Title: Reducing the impact of diabetic foot ulcers on patients and the health service: the REDUCE programme
Funder: Department of Health and Social Care

Abstract: Question: Can we reduce the impact and costs of diabetic foot ulcers (DFUs) on patients and the NHS, through a complex intervention which targets the psychological/behavioural risk factors associated with ulcer recurrence and healing? Background: One in 17 people in the UK has diabetes. DFUs are common, chronic and costly complications of the disease: affecting 25% of patients, less than half of whom will be ulcer-free after 6 months of treatment. The physical and emotional burden is also considerable: 32% of patients are depressed and this is related to a 3-fold greater risk of mortality. In 2014-15, the NHS spent approximately &pound;1 billion on diabetic foot care. Previous ulceration is the single greatest risk factor for ulceration: with 40% of patients re-ulcerating within 12 months. NICE guidance on the management of these high-risk patients has significant limitations; relying on referral to foot-protection teams and education . However education is not defined and recommended on the basis of expert opinion not research. Indeed, successive systematic reviews indicate education alone does not improve clinical outcomes. Furthermore, the guidance neglects psychological/behavioural risk factors, despite evidence they play a role. We have previously developed a complex intervention (REDUCE) which targets the psychological/behavioural risk-factors associated with DFU recurrence and healing. This requires evaluation. In addition, we have identified that patients would welcome an additional digital intervention to support long-term change in these risk factors. Thus, this programme aims to: Develop the REDUCE digital intervention and training programme; Test the intervention and trial procedures in a pilot trial; Evaluate whether and how REDUCE works; Determine if it is cost-effective; Identify the patient and NHS factors which could influence how REDUCE is implemented. Methods: The programme involves 6 work-packages (WPs). WP1 will take a person-based approach to intervention development; and the training programme will be developed in conjunction with our PPI group. The pilot trial (WP2) will use qualitative methods to explore whether REDUCE, the training programme, logic model or intervention fidelity tool need refining; and will monitor recruitment, questionnaire completion rates and outcome data capture. The main trial (WP3) will measure whether REDUCE significantly increases ulcer-free days in patients at risk of re-ulceration. A mixed-methods process evaluation will examine how REDUCE works, for whom and intervention fidelity (WP4). WP5 will assess cost-effectiveness. WP6a will survey providers and commissioners to explore perceived barriers and facilitators to offering REDUCE. Predictive computer modelling will examine who benefits most from REDUCE and in what ways (WP6b). Timelines: A 72 month programme: development work (WPs1&2) occurring during 0-21m; main trial (WP3) and WP4 over 22-66m (analyses and dissemination 67-72m); WP5&6 running across the programme. Impact/Dissemination: If REDUCE is effective, a 15% increase in the number of patients who are ulcer-free could save the NHS &pound;105 million per annum. The findings could also trigger a paradigm shift in the management of DFUs and other chronic conditions by demonstrating how modifying psychological/behavioural risk factors can improve outcomes for patients and the NHS. We will share findings with patient, academic, clinical and commissioning audiences.

Lay abstract: 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. &pound;1 in every &pound;140 spent in the NHS goes towards DFU treatments. Current treatments to prevent and heal ulcers do not work well. Patient education is recommended to prevent ulcers, but education alone does not work. The evidence for treatments to encourage healing is also unclear. People s thoughts, feelings and behaviours can affect the risk of getting DFUs and how they heal. We developed a treatment (REDUCE) 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. In a Programme Development Grant we established that, while the core content of REDUCE does not need to be changed, most people would prefer to receive the second part of REDUCE (long-term support) from a website. We also concluded that the best way to assess if REDUCE works would be to record the number of days people are ulcer-free and measure the costs of REDUCE to patients, the NHS and society. This programme aims to: Develop the digital component of REDUCE, the REDUCE training programme and finalise the procedures for the main trial; See whether and how REDUCE works; and if any benefit is worth the cost; Identify the person and NHS factors which could influence how REDUCE is offered. To achieve these aims we will first develop the REDUCE maintenance intervention (website and booklet) for people with diabetes; and the REDUCE training programme for healthcare professionals (Work-Packages1a&b). We will then, in a small trial, explore whether: REDUCE; the training programme; or trial procedures need changing before conducting the main trial (Work-Package2). In the main trial, we will randomly allocate people at risk of ulcers to receive REDUCE or their usual treatment; and will measure whether REDUCE affects how long people are ulcer-free over an 18 month period (Work-Package3). We will also explore how REDUCE works and for whom; how well it was delivered (Work-Package4); and whether it offers value for money (Work-Package5). Finally, we will explore with health-care providers and commissioners their willingness and ability to provide REDUCE; and explore if some people benefit more from REDUCE than others, and in what ways (Work-Packages6a&b). Our PPI panel contributed to this application and will be active in all Work-Packages. We will share findings with people with diabetes, academics, clinicians and those who commission services.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;7.3 MANAGEMENT AND DECISION MAKING
Health categories: SKIN;METABOLIC AND ENDOCRINE