BACKGROUND: Ulceration of the feet, which can result in loss of limbs and even death, is one of the major health problems for people with diabetes mellitus. OBJECTIVES: To assess the effects of patient education on the prevention of foot ulcers in patients with diabetes mellitus. SEARCH STRATEGY: Eligible studies were identified by searching the Cochrane Wounds Group Specialised Register (22 December 2009), the Cochrane Central Register of Controlled Trials (Cochrane Library 2009 Issue 4 ), Ovid MEDLINE (1950 to November Week 3 2009), Ovid MEDLINE In-Process & Other Non-Indexed Citations (Searched 22/12/09), Ovid EMBASE (1980 to 2009 Week 51) and EBSCO CINAHL (1982 to December 22 2009). SELECTION CRITERIA: Prospective randomised controlled trials (RCTs) which evaluated educational programmes for preventing foot ulcers in people with diabetes mellitus. There was no restriction on language of the publications. DATA COLLECTION AND ANALYSIS: Two review authors independently undertook data extraction and assessment of risk of bias. Primary end-points were foot ulceration or ulcer recurrence and amputation. MAIN RESULTS: Eleven RCTs were included. Three studies described the effect of foot care education as part of general diabetes education compared with usual care. Two studies examined the effect of foot care education tailored to educational needs compared with no intervention. Finally, six studies described the effect of intensive compared with brief educational interventions. Pooling of outcome data was precluded by marked, mainly clinical, heterogeneity. Four RCTs assessed the effect of patient education on primary end-points: foot ulceration and amputations. One of these studies reported a statistically significant benefit of one hour group education after one year of follow-up in people with diabetes who were at high risk for foot ulceration; RR amputation 0.33 (95% CI 0.15 to 0.76); RR ulceration 0.31 (95% CI 0.14 to 0.66), however this study was at high risk of bias and may have overestimated the effect due to a unit of analysis error. One similar, but methodologically superior study did not confirm this finding; RR amputation 0.98 (95% CI 0.41 to 2.34); RR ulceration 1.00 (95% CI 0.70 to 1.44). The other two studies did not detect any effect of education on ulcer incidence or amputation but were underpowered. Patients' foot care knowledge was improved in the short term in five of eight RCTs in which this outcome was assessed, as was patients' self reported self care behaviour in the short term in seven of nine RCTs. The effects on callus, nail problems and fungal infections were described in five of the included studies, of which only two reported temporary improvements after an educational intervention.Only one of the included RCTs was considered to be at low risk of bias. AUTHORS' CONCLUSIONS: Most of the RCTs included in this review are at high or unclear risk of bias. In some trials, foot care knowledge and self reported patient behaviour seem to be positively influenced by education in the short term. This, however, must be viewed with caution. The ultimate goal of educational interventions is preventing foot ulceration and amputation but only four RCTs reported these outcomes and only two reported sufficient data to examine this. Based on these two studies, we conclude that there is insufficient robust evidence that limited patient education alone is effective in achieving clinically relevant reductions in ulcer and amputation incidence.Future research should focus on evaluating the effect of more comprehensive and/or intensive prevention strategies which may also include patient education (complex interventions).
BACKGROUND: Ulceration of the feet, which can result in loss of limbs and even death, is one of the major health problems for people with diabetes mellitus. OBJECTIVES: To assess the effects of patient education on the prevention of foot ulcers in patients with diabetes mellitus. SEARCH STRATEGY: Eligible studies were identified by searching the Cochrane Wounds Group Specialised Register (22 December 2009), the Cochrane Central Register of Controlled Trials (Cochrane Library 2009 Issue 4 ), Ovid MEDLINE (1950 to November Week 3 2009), Ovid MEDLINE In-Process & Other Non-Indexed Citations (Searched 22/12/09), Ovid EMBASE (1980 to 2009 Week 51) and EBSCO CINAHL (1982 to December 22 2009). SELECTION CRITERIA: Prospective randomised controlled trials (RCTs) which evaluated educational programmes for preventing foot ulcers in people with diabetes mellitus. There was no restriction on language of the publications. DATA COLLECTION AND ANALYSIS: Two review authors independently undertook data extraction and assessment of risk of bias. Primary end-points were foot ulceration or ulcer recurrence and amputation. MAIN RESULTS: Eleven RCTs were included. Three studies described the effect of foot care education as part of general diabetes education compared with usual care. Two studies examined the effect of foot care education tailored to educational needs compared with no intervention. Finally, six studies described the effect of intensive compared with brief educational interventions. Pooling of outcome data was precluded by marked, mainly clinical, heterogeneity. Four RCTs assessed the effect of patient education on primary end-points: foot ulceration and amputations. One of these studies reported a statistically significant benefit of one hour group education after one year of follow-up in people with diabetes who were at high risk for foot ulceration; RR amputation 0.33 (95% CI 0.15 to 0.76); RR ulceration 0.31 (95% CI 0.14 to 0.66), however this study was at high risk of bias and may have overestimated the effect due to a unit of analysis error. One similar, but methodologically superior study did not confirm this finding; RR amputation 0.98 (95% CI 0.41 to 2.34); RR ulceration 1.00 (95% CI 0.70 to 1.44). The other two studies did not detect any effect of education on ulcer incidence or amputation but were underpowered. Patients' foot care knowledge was improved in the short term in five of eight RCTs in which this outcome was assessed, as was patients' self reported self care behaviour in the short term in seven of nine RCTs. The effects on callus, nail problems and fungal infections were described in five of the included studies, of which only two reported temporary improvements after an educational intervention.Only one of the included RCTs was considered to be at low risk of bias. AUTHORS' CONCLUSIONS: Most of the RCTs included in this review are at high or unclear risk of bias. In some trials, foot care knowledge and self reported patient behaviour seem to be positively influenced by education in the short term. This, however, must be viewed with caution. The ultimate goal of educational interventions is preventing foot ulceration and amputation but only four RCTs reported these outcomes and only two reported sufficient data to examine this. Based on these two studies, we conclude that there is insufficient robust evidence that limited patient education alone is effective in achieving clinically relevant reductions in ulcer and amputation incidence.Future research should focus on evaluating the effect of more comprehensive and/or intensive prevention strategies which may also include patient education (complex interventions).