several studies , including some randomized controlled trials [ 1 , 2 ] , have shown that patient education is capable of reducing the risk for diabetic foot ulcers . however , specific education on foot ulcer prevention is often included in broader programs addressing different parts of diabetes care [ 16 ] , or provided with time- and resource - consuming curricula . some trials have explored the efficacy of dedicated educational interventions for prevention of foot ulceration , usually with individual sessions [ 710 ] ; some of those trials [ 7 , 8 ] had a short - term follow - up , providing no data on the effect of the intervention on the incidence of new ulcers . one trial had a long - term ( 7-year ) follow - up , but the patients enrolled had a low risk of foot ulcers , so that the number of events observed was not sufficient to draw clear conclusions . group educational programs could theoretically be more cost - effective than individual patient education . in a randomized trial , a 1-hour group educational program reduced the incidence of amputation and new ulcerations in diabetic patients with foot infection , ulceration , or prior amputation referred for podiatry or vascular surgery . though interesting , the results of that latter trial can not be easily extended to patients with a lower risk profile . considering that available resources are limited , brief and inexpensive educational programs have a greater chance of being applied in routine clinical practice . although longer and more intensive educational programs were reported to be more effective than brief interventions for foot ulcer prevention , other studies failed to detect significant differences between these two approaches [ 4 , 5 ] . a properly designed brief program could produce some beneficial effect with a limited use of resources . in addition , the selection of patients at higher risk could be crucial for cost - effectiveness of patient education . the aim of the present study is to assess the feasibility and efficacy of a brief educational program for the prevention of diabetic foot ulcers in high - risk patients referring to a diabetes outpatient clinic . this study , designed as a randomized , open - label , single - center clinical trial , with a 6-month follow - up , was approved by the local ethical committee . the study was performed on outpatients aged 18 years , affected by type 2 diabetes , who fulfilled at least one of the following three criteria ( for definition of high risk of foot ulcers ) : diagnosis of neuropathy , previous diabetic foot ulcer , or foot abnormalities at risk for ulcer in the opinion of the investigator . patients with peripheral vascular disease requiring immediate revascularization , as well as those with cognitive impairment , were excluded . all patients had previously received standard multidisciplinary education for diabetes ( with a structured group program at diagnosis or first contact , and follow - up meetings every two years ) , but no educational intervention specifically focused on foot care . after providing written informed consent , patients were randomized in a 1  :  1 ratio either to intervention or to control group . the randomization procedure was based on a computer - generated list held by an independent randomization center ( diabetes agency ) that was contacted by telephone each time a person was randomized . the intervention was a two - hour program provided to groups of 57 patients ( mean : n = 6 ) , including a 30-minute face - to - face lesson on risk factors for foot ulcers , and a 90-minute interactive session with practical exercises on behaviors for reducing risk . the intervention involved a physician ( for 15 minutes ) and a nurse ( for the remaining 105 minutes ) . patients randomized to control group were provided with a brief leaflet with some recommendations for ulcer prevention , as suggested by local guidelines . at randomization , the pin ( patient interpretation of neuropathy ) questionnaire was administered to the patients , exploring patients ' knowledge about signs and symptoms of neuropathy and risk factors for foot ulcers onset . in patients randomized to intervention follow - up visits were planned at 3 and 6 months from randomization , for foot examination . patients who did not show up at control visits were actively contacted through telephone calls . in patients who developed ulcers , the number of visits at the foot clinic ( performed either by physician or by nurse ) was recovered from administrative databases of hospital activity ; physicians ' and nurses ' visits are scheduled every 30 and 20 minutes , respectively . the power calculation , based on the incidence of ulcers observed in previous studies , suggested the enrolment of 100 patients per group to detect a 20% between - group difference ( power 80% , p < 0.05 , and drop - out 2% ) . for statistical analysis , continuous variables ( expressed as mean  sd or as median [ quartiles ] ) were compared between groups with unpaired student 's t - tests or mann - whitney u tests , whenever appropriate . relative risk of incident foot ulcers ( with 95% confidence interval , 95% ci ) was calculated using kaplan - meier method . the study was prematurely terminated due to a highly significant difference in outcome between the two treatment groups . one patient ( in the intervention group ) was lost at follow - up and was therefore excluded from the analysis . the baseline characteristics of the final sample are summarized in table 1 , and they did not differ between the two groups . patients allocated to the intervention group showed a trend toward reduction of hba1c and bmi at 6 months , which did not reach statistical significance , whereas blood pressure levels did not show any change ( table 2 ) . two patients died during follow - up ( one in the standard care and one in the interventional group ) ; none of them had developed ulcers , and they were included in the analysis until death . six patients , all in the control group , developed ulcers during the 6-month follow - up ( 10% versus 0% , p = 0.012 ; figure 1 ) . questionnaire scores improved significantly after intervention ( 20 [ 16 ; 22 ] versus 23 [ 21 ; 24 ] , p < 0.001 ) . time spent for intervention was 150 and 1050 minutes ( 2.5 and 17.5 minutes per patient ) for physician and nurse , respectively , whereas time spent for ulcer care in the control group was 390 and 1200 minutes ( 6.5 and 20 minutes for each patient randomized to control ) . a brief , 2-hour , focused group educational program is effective in preventing diabetic foot ulcers in high - risk patients , as previously reported in another study . with respect to the trial by malone et al . , the present study was performed on patients with a lower overall risk profile , referring to a diabetes outpatient clinic . these findings were not reproduced in the other studies [ 6 , 9 ] , probably due to insufficient sample size . the strategy of targeting for intervention only those patients who are at higher risk can improve cost - efficacy . in fact , in the described context , the time spent by health professional in training patients in the intervention group was smaller than that used for the treatment of preventable ulcers in the control group . the approach used , based on interactivity and practical demonstrations , and aimed at improving skills , rather than formal knowledge , provided interesting clinical results . this is a single - center trial , performed by highly trained health professionals working in a diabetic foot clinic ; the reproducibility of this program in a different setting should be verified . the cost of drugs and materials used for the treatment of ulcers was not assessed , leading to an underestimation of the direct costs in the control group . although patients ' knowledge was improved by the intervention , no data were collected on patients ' skills or actual behaviors during follow - up . in addition , the therapeutic effects of patient education tend to fade with time ; the durability of the beneficial effects of this program needs to be formally tested in a study with a longer follow - up . despite these limitations , the proposed intervention appears to provide a sustainable and effective approach to targeted education for diabetic foot ulcer prevention .
background . 
 patient education is capable of reducing the risk for diabetic foot ulcers . 
 however , specific education on foot ulcer prevention was either included in broader programs addressing different parts of diabetes care or provided with time- and resource - consuming curricula . 
 the aim of the study is to assess the feasibility and efficacy of a brief educational program for the prevention of diabetic foot ulcers in high - risk patients 
 . methods . 
 the study was performed on type 2 diabetic patients , randomized in a 1  :  1 ratio either to intervention or to control group . 
 the principal endpoint was the incidence of foot ulcers . 
 the intervention was a two - hour program provided to groups of 57 patients , including a 30-minute face - to - face lesson on risk factors for foot ulcers , and a 90-minute interactive session with practical exercises on behaviors for reducing risk . 
 results . 
 the study was prematurely terminated due to a highly significant difference in outcome between the two treatment groups . 
 the final sample was therefore composed of 121 patients . 
 six patients , all in the control group , developed ulcers during the 6-month follow - up ( 10% versus 0% , p = 0.012 ) 
 . conclusions . 
 a brief , 2-hour , focused educational program is effective in preventing diabetic foot ulcers in high - risk patients .