***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: Specially design ed Thor-Lo footwear has been shown to reduce the in-shoe foot pressures in diabetic patients at risk of foot ulceration when compared to their own footwear .  Fifty at high risk patients 32 ( 64 % ) males , 17 ( 34 % ) type 1 diabetes ) have been provided with this foot wear  and have been followed up for 6 months . Mean age was 57.6 ( range , 34 - 78 ) years , duration of diabetes 22.4 ( range , 4 - 50 ) years , Neuropathy Symptom Score 3.36 + /- 2.96 ( mean + /- S.D. ) , Neuropathy Disability Score 16.8 + /- 6.83 , VPT 43.4 + /- 11.8 Volts while 43 ( 86 % ) could not feel a 5.07 or smaller Semmes-Weinstein monofilament . Forty-two ( 84 % ) patients were re-examined at an interim visit 3 months after baseline , while 37 ( 74 % ) completed the study . In-shoe peak forces and pressures were measured using the F-Scan system . No difference was found among the peak force among baseline ( 95.5 + /- 26 kg ) , interim ( 96.5 + /- 33 ) and final visit ( 97.7 + /- 25.2 , P + NS ) . There was no difference in peak pressures at the baseline ( 3.98 + /- 1.42 kg.cm-2 ) , second visit ( 4.13 + /- 2.30 ) and the final visit ( 4.25 + /- 1.51 ) . Nine ( 18 % ) patients developed foot problems and one died during the study . We conclude that no changes in foot pressures were found over a period of 6 months of continuous usage of the specially design ed footwear in a group of diabetic patients at risk of foot ulceration . Further prospect i ve studies are required to evaluate the impact of specially design ed footwear in reducing the rate of foot ulceration OBJECTIVE Little prospect i ve research exists on risk factors for diabetic foot ulcer that considers the independent effects of multiple potential etiologic agents . We prospect ively studied the effects of diabetes characteristics , foot deformity , behavioral factors , and neurovascular function on foot ulcer risk among 749 diabetic veterans with 1,483 lower limbs . RESEARCH DESIGN AND METHODS Eligible subjects included all diabetic enrollees of a general internal medicine clinic without foot ulcer , of whom 83 % agreed to participate . Baseline assessment included history and lower-limb physical examination , tests for sensory and autonomic neuropathy , and measurements of macro- and microvascular perfusion in the foot .  Subjects were followed for the occurrence of a full thickness skin defect on the foot that took > 14 days to heal , with a mean follow-up of 3.7 years . RESULTS Using stepwise Cox regression analysis , the following factors were independently related to foot ulcer risk : foot insensitivity to the 5.07 monofilament ( relative risk [ 95 % CI ] ) 2.2 ( 1.5 - 3.1 ) , past history of amputation 2.8 ( 1.8 - 4.3 ) or foot ulcer 1.6 ( 1.2 - 2.3 ) , insulin use 1.6 ( 1.1 - 2.2 ) , Charcot deformity 3.5 ( 1.2 - 9.9 ) , 15 mmHg higher dorsal foot transcutaneous PO2 0.8 ( 0.7 - 0.9 ) , 20 kg higher body weight 1.2 ( 1.1 - 1.4 ) , 0.3 higher ankle-arm index 0.8 ( 0.7 - 1.0 ) , poor vision 1.9 ( 1.4 - 2.6 ) , and 13 mmHg orthostatic blood pressure fall 1.2 ( 1.1 - 1.5 ) . Higher ulcer risk was associated with hammer/claw toe deformity and history of laser photocoagulation in certain subgroups . Unrelated to foot ulcer risk in multivariate models were diabetes duration and type , race , smoking status , diabetes education , joint mobility , hallux blood pressure , and other foot deformities . CONCLUSIONS Certain foot deformities , reduced skin oxygenation and foot perfusion , poor vision , greater body mass , and both sensory and autonomic neuropathy independently influence foot ulcer risk , thereby providing support for a multifactorial etiology for diabetic foot ulceration Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field OBJECTIVE Custom-made footwear is the treatment of choice to prevent foot ulcer recurrence in diabetes . This footwear primarily aims to offload plantar regions at high ulcer risk . However , ulcer recurrence rates are high . We assessed the effect of offloading-improved custom-made footwear and the role of footwear adherence on plantar foot ulcer recurrence . RESEARCH DESIGN AND METHODS We r and omly assigned 171 neuropathic diabetic patients with a recently healed plantar foot ulcer to custom-made footwear with improved and subsequently preserved offloading ( ∼20 % peak pressure relief by modifying the footwear ) or to usual care ( i.e. , nonimproved custom-made footwear ) . Primary outcome was plantar foot ulcer recurrence in 18 months . Secondary outcome was ulcer recurrence in patients with an objective ly measured adherence of ≥80 % of steps taken . RESULTS On the basis of intention-to-treat , 33 of 85 patients ( 38.8 % ) with improved footwear and 38 of 86 patients ( 44.2 % ) with usual care had a recurrent ulcer ( relative risk −11 % , odds ratio 0.80 [ 95 % CI 0.44–1.47 ] , P = 0.48 ) . Ulcer-free survival curves were not significantly different between groups ( P = 0.40 ) . In the 79 patients ( 46 % of total group ) with high adherence , 9 of 35 ( 25.7 % ) with improved footwear and 21 of 44 ( 47.8 % ) with usual care had a recurrent ulcer ( relative risk −46 % , odds ratio 0.38 [ 0.15–0.99 ] , P = 0.045 ) . CONCLUSIONS Offloading-improved custom-made footwear does not significantly reduce the incidence of plantar foot ulcer recurrence in diabetes compared with custom-made footwear that does not undergo such improvement , unless it is worn as recommended OBJECTIVE To assess the efficacy of in-shoe orthoses that were design ed based on shape and barefoot plantar pressure in reducing the incidence of submetatarsal head plantar ulcers in people with diabetes , peripheral neuropathy , and a history of similar prior ulceration . RESEARCH DESIGN AND METHODS Single-blinded multicenter r and omized controlled trial with subjects r and omized to wear shape- and pressure-based orthoses ( experimental , n = 66 ) or st and ard-of-care A5513 orthoses ( control , n = 64 ) . Patients were followed for 15 months , until a study end point ( forefoot plantar ulcer or nonulcerative plantar forefoot lesion ) or to study termination . Proportional hazards regression was used for analysis . RESULTS There was a trend in the composite primary end point ( both ulcers and nonulcerative lesions ) across the full follow-up period ( P = 0.13 ) in favor of the experimental orthoses . This trend was due to a marked difference in ulcer occurrence ( P = 0.007 ) but no difference in the rate of nonulcerative lesions ( P = 0.76 ) . At 180 days , the ulcer prevention effect of the experimental orthoses was already significant ( P = 0.003 ) when compared with control , and the benefit of the experimental orthoses with respect to the composite end point was also significant ( P = 0.042 ) . The hazard ratio was 3.4 ( 95 % CI 1.3–8.7 ) for the occurrence of a submetatarsal head plantar ulcer in the control compared with experimental arm over the duration of the study . CONCLUSIONS We conclude that shape- and barefoot plantar pressure – based orthoses were more effective in reducing submetatarsal head plantar ulcer recurrence than current st and ard-of-care orthoses , but they did not significantly reduce nonulcerative lesions Various foot structures are thought to influence forefoot plantar pressures during walking . High peak plantar pressures ( PPP ) during walking in people with diabetes mellitus ( DM ) and peripheral neuropathy ( PN ) can cause skin breakdown . The question addressed by this study is " What are the primary forefoot structural factors that predict regional PPP during walking in groups of people with and without DM and PN ? " Twenty people with DM and PN ( mean age 55+/-9 years , 6 female , 14 male , BMI = 33+/-8 ) and 20 people without DM , matched for gender , age , and BMI were tested . Measures of foot structure were taken from three-dimensional images constructed from spiral X-ray computed tomography .  Peak plantar pressure data were recorded during walking . Hierarchical multiple regression analysis was used to predict regional PPP at the great toe and five metatarsal heads from selected structural and walking variables . Metatarsal phalangeal joint angle ( hammer toe deformity ) was the most important variable predicting pressure , accounting for 19 - 45 % of the PPP variance at five of the six locations in the DM group . Soft tissue thickness , hallux valgus , and forefoot arthropathy were the most important predictors of PPP in the control group . Combinations of structural and walking variables accounted for 47 - 71 % of the variance in the DM group and 52 - 83 % of the variance of PPP during walking in the control group . These structural variables , especially hammer toe deformity , should be considered in attempts to develop strategies to reduce excessive forefoot PPP that may contribute to skin breakdown or other injury OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity A longitudinal double-blind study was conducted to determine the effect of sock fiber composition on the frequency and size of blistering events in long-distance runners . Thirty- 
    Output:
    
The evidence to support to use of padded socks is limited .
There is a suggestion these simple-to-use interventions could be of value , particularly in terms of plantar pressure reduction .
The socks were generally of a sophisticated design with complex use of knit patterns and yarn content .
This systematic review provides limited support for the use of  padded socks in the diabetic population to protect vulnerable feet .