The prevention and treatment of diabetic foot ulcers: a review of clinical effectiveness studies

Diabetic foot ulcers are associated with considerable morbidity, mortality and costs to the NHS. This paper describes a review of publications reporting randomised controlled trials examining the clinical effectiveness of interventions for diabetic foot ulcers for 1986–1996. Only 23 studies were identified that described randomised controlled trials and, of these, only 4 fulfilled three criteria shown to influence reliability of results: adequate description of randomisation, double blinding and description of withdrawals and drop‐outs. No cost‐effectiveness studies conducted alongside trials were identified from the searches. This shortage of rigorous trials highlights the need for more well designed research in the prevention and treatment of diabetic foot ulcers to determine clinical effectiveness as well as relative cost‐effectiveness.