Commentary

Foot complications in people with diabetes are an important cause of morbidity and mortality. They are expensive to treat and often require admission to hospital for surgery and rehabilitation; therefore, preventing them should be a priority.¹ Few good quality trials exist on the treatment of foot ulceration in diabetes.² Current best practice emphasises regular and thorough wound debridement and avoidance of weight bearing activities. Armstrong and Nguyen used these principles in all their patients, and their study adds to our understanding of the pathogenesis of foot ulcers by showing that less oedema is associated with better healing.

This study raises some minor concerns. Although the mean baseline wound size did not differ between the groups, the mean and standard deviation were both smaller in the actively treated patients, which might suggest a baseline imbalance in the numbers of large ulcers. More ulcers affected the mid or hind foot in the placebo group (38% v 29%). 16% of patients dropped out of the study for various reasons, and a substantial number in both groups (numbers unspecified) were unable to tolerate the device for 8 hours/day. The proportions of ischaemic and neuropathic ulcers were also not reported.

None the less, this carefully done randomised controlled trial is welcome. Its hypothesis is well founded, and the results are promising if not quite conclusive. A further study with randomisation by ulcer size, location, and cause is needed before regular use of these devices can be recommended. Meanwhile, the impressive healing rate of >50% in the placebo group by using expert debridement underlines the importance of this treatment for all our patients.