Background: Foot wounds in people with diabetes mellitus (DM) are a common and serious global health issue. Negative pressure wound therapy can be used to treat these wounds and a clear and current overview of current evidence is required to facilitate decision-making regarding its use.

Objectives: To assess the effects of negative pressure wound therapy compared with standard care or other adjuvant therapies in the healing of foot wounds in people with DM.

Search methods: In July 2013, we searched the following databases to identify reports of relevant randomised controlled trials (RCTs): Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL); The Database of Abstracts of Reviews of Effects (DARE); The NHS Economic Evaluation Database; Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL.

Selection criteria: Published or unpublished RCTs that evaluate the effects of any brand of negative pressure wound therapy in the treatment of foot wounds in people with diabetes, irrespective of publication date or language of publication. Particular effort was made to identify unpublished studies.

Data collection and analysis: Two review authors independently performed study selection, risk of bias assessment and data extraction.

Main results: We included five studies in this review randomising 605 participants. Two studies (total of 502 participants) compared negative pressure wound therapy with standard moist wound dressings. The first of these was conducted in people with DM and post-amputation wounds and reported that significantly more people healed in the negative pressure wound therapy group compared with the moist dressing group: (risk ratio 1.44; 95% CI 1.03 to 2.01). The second study, conducted in people with debrided foot ulcers, also reported a statistically significant increase in the proportion of ulcers healed in the negative pressure wound therapy group compared with the moist dressing group: (risk ratio 1.49; 95% CI 1.11 to 2.01). However, these studies were noted to be at risk of performance bias, so caution is required in their interpretation. Findings from the remaining three studies provided limited data, as they were small, with limited reporting, as well as being at unclear risk of bias.

Authors' conclusions: There is some evidence to suggest that negative pressure wound therapy is more effective in healing post-operative foot wounds and ulcers of the foot in people with DM compared with moist wound dressings. However, these findings are uncertain due to the possible risk of bias in the original studies. The limitations in current RCT evidence suggests that further trials are required to reduce uncertainty around decision making regarding the use of NPWT to treat foot wounds in people with DM.