Abstract
To identify and synthesize the evidence for the effectiveness of psychosocial interventions to promote the healing, and/or reduce the occurrence of, foot ulceration in people with diabetes. In March 2019 we searched CENTRAL, Medline, Embase and PsycInfo for randomized controlled trials of interventions with psychosocial components for people with diabetes. The primary outcomes of this review were foot ulceration and healing. We assessed studies using the Cochrane risk-of-bias tool, the TIDieR checklist and GRADE. We conducted narrative synthesis and random-effects meta-analysis. We included 31 randomized controlled trials (4511 participants), of which most (24 randomized controlled trials, 4093 participants) were prevention studies. Most interventions were educational with a modest psychosocial component. Ulceration and healing were not reported in most studies; secondary outcomes varied. Evidence was of low or very low quality because of high risks of bias and imprecision, and few studies reported adherence or fidelity. In groups where participants had prior ulceration, educational interventions had no clear effect on new ulceration (low-quality evidence). Two treatment studies, assessing continuous pharmacist support and an intervention to promote understanding of well-being, reported healing but their evidence was also of very low quality. Most psychosocial intervention randomized controlled trials assessing foot ulcer outcomes in people with diabetes were prevention studies, and most interventions were primarily educational. Ulcer healing and development were not well reported. There is a need for better understanding of psychological and behavioural influences on ulcer incidence, healing and recurrence in people with diabetes. Randomized controlled trials of theoretically informed interventions, which assess clinical outcomes, are urgently required. (PROSPERO registration: CRD42016052960).
Highlights
Diabetes mellitus is an increasingly common condition that is expected to affect more than 578 million people globally by 2030 [1]
There is a need for better understanding of psychological and behavioural influences on ulcer incidence, healing and recurrence in people with diabetes
Foot ulcers in people with diabetes have a serious impact on health-related quality of life [9,10,11], and the cost of treatment for diabetic foot ulceration to the National Health Service (NHS) in England was estimated at £837m to £962m in 2014– 2015 [12]
Summary
Diabetes mellitus is an increasingly common condition that is expected to affect more than 578 million people globally by 2030 [1]. Success in treating diabetes has improved the life expectancy of those affected; increased prevalence, coupled with the extended time people live with diabetes, has led to increased numbers of diabetes-related complications, including foot ulceration (defined as a wound that extends through the full thickness of the skin below the level of the ankle, irrespective of duration) [2]. Foot ulcers in people with diabetes have a serious impact on health-related quality of life [9,10,11], and the cost of treatment for diabetic foot ulceration to the National Health Service (NHS) in England was estimated at £837m to £962m in 2014– 2015 [12]. Economic impact is high in terms of personal costs a 2020 The Authors
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