Aims: To identify and synthesise the evidence for the effectiveness of psychosocial interventions to promote the healing, and/or reduce the occurrence of, foot ulceration in people with diabetes.
Methods: In March 2019 we searched CENTRAL, Medline, Embase and PsycInfo, for randomised controlled trials (RCTs) of interventions with psychosocial components for people with diabetes. Review primary outcomes 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 randomeffects meta-analysis. PROSPERO registration: CRD42016052960
Results: We included 31 RCTs (4511 participants); most (24 RCTs, 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 low or very low quality due to 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 wellbeing, reported healing but were also very low quality evidence.
Conclusion: Most psychosocial intervention RCTs assessing foot ulcer outcomes in people with diabetes are prevention studies; 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. RCTs of
theoretically–informed interventions, which assess clinical outcomes, are urgently required.