***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: PURPOSE To evaluate the effectiveness of home temperature monitoring to reduce the incidence of foot ulcers  in high-risk patients with diabetes . METHODS In this physician-blinded , 18-month r and omized controlled trial , 225 subjects with diabetes at high risk for ulceration were assigned to st and ard therapy ( St and ard Therapy Group ) or dermal thermometry ( Dermal Thermometry Group ) groups . Both groups received therapeutic footwear , diabetic foot education , regular foot care , and performed a structured foot inspection daily . Dermal Thermometry Group subjects used an infrared skin thermometer to measure temperatures  on 6 foot sites twice daily . Temperature differences > 4 degrees F between left and right corresponding sites triggered patients to contact the study nurse and reduce activity until temperatures normalized . RESULTS A total of 8.4 % ( n=19 ) subjects ulcerated over the study period . Subjects were one third as likely to ulcerate in the Dermal Thermometry Group compared with the St and ard Therapy Group ( 12.2 % vs 4.7 % , odds ratio 3.0 , 95 % confidence interval , 1.0 to 8.5 , P=.038 ) . Proportional hazards regression analysis suggested that thermometry intervention was associated with a significantly longer time to ulceration ( P=.04 ) , adjusted for elevated foot ulcer classification ( International Working Group Risk Factor 3 ) , age , and minority status . Patients that ulcerated had a temperature difference that was 4.8 times greater at the site of ulceration in the week before ulceration than did a r and om 7 consecutive-day sample of 50 other subjects that did not ulcerate ( 3.50+/-1.0 vs 0.74+/-0.05 , P=.001 ) . CONCLUSIONS High temperature gradients between feet may predict the onset of neuropathic ulceration and self-monitoring may reduce the risk of ulceration Abstract Aims /hypothesisThis observer-blind , r and omised controlled trial was design ed to determine the effect of a foot care education programme in the secondary prevention of foot ulcers . Methods People with newly healed foot ulcers attending one of three specialist clinics were allocated to receive either targeted , one-to-one education or usual care , using a computer-generated r and om allocation sequence that had been prepared in advance but which was concealed from the clinical research er . The primary outcome was ulcer incidence at 12 months . Secondary outcomes were ulcer incidence at 6 months and incidence of amputation , mood ( Hospital Anxiety and Depression Scale ) and quality of life ( Diabetic Foot Ulcer Scale ) at 6 and 12 months . Protective foot care behaviours ( Nottingham Assessment of Functional Footcare ) were assessed at 12 months . Results There were 87 ( mean [ SD ] age 63.5 [ 12.1 ] years ) patients in the intervention group and 85 control patients ( mean [ SD ] age 64.9 [ 10.9 ] years ) . The groups were comparable at baseline . No significant differences ( p > 0.05 ) were observed between groups in ulcer incidence at either 6 months ( intervention 30 % , control 21 % ) or 12 months ( intervention 41 % , control 41 % ) . Recommended foot care behaviours at 12 months were better in the intervention than in the control group ( p = 0.03 ) , but education had no significant ( p > 0.05 ) effect on mood , quality of life or amputations . Conclusions /interpretationEven though the intervention was associated with improved foot care behaviour , there was no evidence that this programme of targeted education was associated with clinical benefit in this population when compared with usual care . The usefulness and optimal delivery of education to such a high-risk group requires further evaluation . Trial registration : Clinical Trials.gov NCT00729456 Funding : Diabetes UK project grant The purpose of this study was to evaluate the effectiveness of the activities of a podiatrist in the outpatient foot care of patients with diabetes . Patients from southwestern Finl and , ages 10 to 80 years , were selected from the national diabetes register . Those without a recent visit to a podiatrist and without any obvious need for foot care ( n=530 ) were r and omized into a podiatric care group ( individual counseling and primary prevention measures , n=267 ) and a control group ( written instructions only , n=263 ) . Knowledge of foot care and self-care habits were evaluated by means of structured interviews , and a podiatric examination  was performed at baseline and 1 and 7 years later . Compared with the baseline scores , the knowledge score was higher at the 7-year follow-up in both the podiatric and control group and similarly in men and women . Self-care score increased in men similarly in both treatment groups . The self-care score for women increased more in the podiatric group during the first year and the difference between the groups remained for up to 7 years . There were no significant differences between the groups in the podiatric findings OBJECTIVE —The purpose of this study was to evaluate the effectiveness of a temperature monitoring instrument to reduce the incidence of foot ulcers in individuals with diabetes who have a high risk for lower extremity complications . RESEARCH DESIGN AND METHODS —In this physician-blinded , r and omized , 15-month , multicenter trial , 173 subjects with a previous history of diabetic foot ulceration were assigned to st and ard therapy , structured foot examination , or enhanced therapy groups . Each group received therapeutic footwear , diabetic foot education , and regular foot care . Subjects in the structured foot examination group performed a structured foot inspection daily and recorded their findings in a logbook . If st and ard therapy or structured foot examinations identified any foot abnormalities , subjects were instructed to contact the study nurse immediately . Subjects in the enhanced therapy group used an infrared skin thermometer  to measure temperatures on six foot sites each day . Temperature differences > 4 ° F ( > 2.2 ° C ) between left and right corresponding sites triggered patients to contact the study nurse and reduce activity until temperatures normalized . RESULTS —The enhanced therapy group had fewer foot ulcers than the st and ard therapy and structured foot examination groups ( enhanced therapy 8.5 vs. st and ard therapy 29.3 % , P = 0.0046 and enhanced therapy vs. structured foot examination 30.4 % , P = 0.0029 ) . Patients in the st and ard therapy and structured foot examination groups were 4.37 and 4.71 times more likely to develop ulcers than patients in the enhanced therapy group . CONCLUSIONS —Infrared temperature home monitoring , in serving as an “ early warning sign , ” appears to be a simple and useful adjunct in the prevention of diabetic foot ulcerations OBJECTIVE To evaluate the influence of podiatrist activities on the outpatient care of diabetic patients in terms of knowledge of diabetic foot care , self-care , and minor foot problems . RESEARCH DESIGN AND METHODS There were 733 patients , aged 10–79 years , identified from the national diabetes register . Patients without recent visits to a podiatrist and without an obvious need for foot care were r and omized into a podiatric care group ( education and primary prevention measures , n = 267 ) and a control group ( written instructions only , n = 263 ) . The patients were examined by an independent study podiatrist at baseline and after 1 year . RESULTS Patients in the podiatrist group had greater improvement in knowledge of diabetic foot care ( P = 0.004 ) and self-care ( P < 0.001 ) scores compared with control subjects . The prevalence of callosities in regions other than the calcaneal region decreased more ( P = 0.009 ) in the podiatrist group ( from 54.5 to 39.5 % ) than in the control group ( from 51.3 to 48.2 % ) , and the size of the callosities decreased more ( P < 0.001 ) in the podiatrist group than in the control group . Reduction in the prevalence of callosities was associated with younger age ( < 50 years ) . CONCLUSIONS Education and primary preventive measures provided individually by a podiatrist result in significant improvements in knowledge and foot self-care scores and in improvements in the prevalence of some minor foot problems . Long-term studies are needed to evaluate whether the intervention of podiatrists starting at an early phase would lead to a reduction in major foot problems Objective . The objective of this study was to assess the impact of a structured follow-up program on the incidence of diabetic foot ulceration ( DFU ) in high-risk diabetic patients . Research Design and Methods . A total of 1874 diabetic patients referred to the Diabetic Foot Unit of the University of Pisa were ranked based on the ulcerative risk score proposed by the International Consensus on Diabetic Foot . Out of 334 patients ( 17.8 % ) with a score ≥2 , 298 accepted to participate in this prospect i ve trial and were r and omized into 2 groups : group A , which received st and ard treatment , and group B , in which the patients received , as a part of a structured prevention program , custom-made orthesis and shoes .  Incidence of new DFUs was observed for no less than 1 year and in a subset of patients after 3 and 5 years , respectively . Incidence of new DFUs and recurrences were considered as primary endpoints to establish the effectiveness of the program ; costs were also compared . Results . Among the patients enrolled in this follow-up analysis , 46 % had neuropathy and deformities , 20 % had previous ulceration , 25 % had previous minor amputation , and 9 % had neuro-osteoarthropathy . During the first 12-month follow-up , 11.5 % of patients in group B developed a DFU compared with 38.6 % in group A ( P < .0001 ) . In the extended follow-up , the cumulative incidence of ulcer in group B compared with group A was 17.6 % versus 61 % ( P < .0001 ) after 3 years and 23.5 % versus 72 % ( P < .0001 ) after 5 years , respectively . The net balance at the end of the follow-up was highly in favor of the prevention program , with a saving of more than € 100 000 per year . Conclusions . The implementation of a structured follow-up with the use of orthesis and shoes can reduce the incidence of DFU  in diabetic patients who are at high ulcerative risk and its related costs BACKGROUND AND OBJECTIVE The use of r and omized consent design s has been subject of method ologic and ethical controversy . In most Western countries , research ethics committees make the decision as to whether a r and omized consent design can be applied . The purpose of the study is to assess to what extent a r and omized consent design and a modification of this design is accepted by research ethics committees , in terms of ethics , health law , and methodology . METHODS A postal survey was conducted among members of research ethics committees in the United Kingdom , and in The Netherl and s , with professional competence in ethics , ( health ) law , methodology , or clinical practice . RESULTS In both the UK and in The Netherl and s , the modified r and omized consent design appears to be statistically significantly more acceptable than the r and omized consent design , with respect to ethical and judicial aspects . The overall rejection rate of the r and omized consent design  was 66 % in the UK and 59 % in The Netherl and s. However , the modified r and omized consent design was rejected by 47 and 41 % in the two countries , respectively . CONCLUSION the modified r and omized consent design appears to be more acceptable than the r and omized consent design . To increase consistency in the way research ethics committees h and le study protocol s , a discussion about the use of r and omized consent design s appears necessary The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement was developed to improve the reporting of r and omised controlled trials . It was initially published in 1996 and focused on the reporting of parallel group r and omised controlled trials . The statement was revised in 2001 , with a further up date in 2010 . A separate CONSORT statement for the reporting of abstract s was published in 2008 . In earlier papers we considered the implication s of the 2001 version of the CONSORT statement for the reporting of cluster r and omised trial . In this paper we provide up date d and extended guidance , based on the 2010 version of the CONSORT statement and the 2008 CONSORT statement for the reporting of abstract s. Participants who received Pies Sanos , a 15-min intervention design ed to improve diabetes self-efficacy and foot self-care behaviors in adult patients with type 2 diabetes who lived in a predominantly Mexican American community , performed more-complete foot self-care 1 month later in their homes . Recruited when they presented for nonurgent care to the emergency department in two community hospitals near the U.S .— Mexico border , participants were r and omized into one of three groups . At follow-up , there was a significant difference in observed foot self-care behaviors between groups , F(2 , 135 ) = 2.99 , p < .05 , as well as a significant difference within the intervention , t ( 47 ) = −4.32 , p < .01 , and control group , t ( 46 ) = −2.06 , p < .05 , for baseline and follow-up self-reported foot self-care behaviors . Baseline diabetes self-efficacy was significantly and positively correlated with both baseline ( r = .335 , p < .001 ) and follow-up ( r = .174 , p < .05 ) foot self-care behaviors OBJECTIVE To evaluate the influence of regular chiropodist 
    Output:
    
There is no high- quality research evidence evaluating complex interventions for preventing  diabetic foot ulceration and insufficient evidence of benefit