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Complex interventions for preventing diabetic foot ulceration.

BACKGROUND
Ulceration of the feet, which can lead to the amputation of feet and legs, is a major problem for people with diabetes mellitus, and can cause substantial economic burden. Single preventive strategies have not been shown to reduce the incidence of foot ulceration to a significant extent. Therefore, in clinical practice, preventive interventions directed at patients, health care providers and/or the structure of health care are often combined (complex interventions).


OBJECTIVES
To assess the effectiveness of complex interventions on the prevention of foot ulcers in people with diabetes mellitus compared with single interventions, usual care or alternative complex interventions. A complex intervention is defined as an integrated care approach, combining two or more prevention strategies on at least two different levels of care: the patient, the healthcare provider and/or the structure of healthcare.


SEARCH STRATEGY
Eligible studies were identified by searching the Cochrane Wounds Group Specialised Register (28/05/09), the Cochrane Central Register of Controlled Trials (CENTRAL, 28 May 2009), Ovid MEDLINE (1950 to May Week 3 2009), Ovid EMBASE (1980 to 2009 Week 21) and EBSCO CINAHL (1982 to May Week 4 2009).


SELECTION CRITERIA
Prospective randomised controlled trials (RCTs) which compared the effectiveness of combinations of preventive strategies, not solely patient education, for the prevention of foot ulcers in people with diabetes mellitus, with single interventions, usual care or alternative complex interventions.


DATA COLLECTION AND ANALYSIS
Two review authors were assigned to independently select studies, to extract study data and to assess risk of bias of included studies, using predefined criteria.


MAIN RESULTS
Only five RCTs met the criteria for inclusion. The study characteristics differed substantially in terms of health care settings, the nature of the interventions studied and outcome measures reported. In three studies that compared the effect of an education centred complex intervention with usual care or written instructions only, little evidence of benefit was found. Two studies compared the effect of more intensive and comprehensive complex interventions with usual care. One of these reported improvement of patients' self care behaviour. In the other study a significant and cost-effective reduction of lower extremity amputations (RR 0.30 (95% CI 0.13 to 0.71)) was achieved. All five included RCTs were at high risk of bias; with hardly any of the predefined quality assessment criteria met.


AUTHORS' CONCLUSIONS
There is no high quality research evidence evaluating complex interventions for preventing diabetic foot ulceration and insufficient evidence of benefit.