***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: 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 OBJECTIVE To assess the efficacy of Sativex , a cannabis-based medicinal extract , as adjuvant treatment in painful diabetic peripheral neuropathy ( DPN ) . RESEARCH DESIGN AND METHODS In this r and omized controlled trial , 30 subjects with painful DPN received daily Sativex or placebo . The primary outcome measure was change in mean daily pain scores , and secondary outcome measures included quality -of-life assessment s. RESULTS There was significant improvement in pain scores in both groups , but mean change between groups was not significant . There were no significant differences in secondary outcome measures . Patients with depression had significantly greater baseline pain scores that improved regardless of intervention . CONCLUSIONS This first-ever trial assessing the efficacy of cannabis has shown it to be no more efficacious than placebo in painful DPN . Depression was a major confounder and may have important implication s for future trials on painful DPN OBJECTIVES To determine the comparative effectiveness and cost-effectiveness of three dressing products , N-A , Inadine and Aquacel , for patients with diabetic foot ulcers , as well as the feasibility and consequences of less frequent dressing changes by health-care professionals . DESIGN A multicentre , prospect i ve , observer-blinded , parallel group , r and omised controlled trial , with three arms . SETTING Established expert multidisciplinary clinics for the management of diabetic foot ulcers across the UK . PARTICIPANTS Patients over age 18 with type 1 or type 2 diabetes with a chronic ( present for at least 6 weeks ) full-thickness foot ulcer ( on or below the malleoli ) not penetrating to tendon , periosteum or bone , and with a cross-sectional area between 25 and 2500 mm(2 ) . INTERVENTIONS Participants were r and omised 1:1:1 to treatment with one of N-A ( a non-adherent , knitted , viscose filament gauze ) , Inadine ( an iodine-impregnated dressing ) , both traditional dressings , or Aquacel , a newer product . MAIN OUTCOME MEASURES The primary outcome measure was the number of ulcers healed in each group at week 24 . Secondary measures included time to healing , new ulcerations , major and minor amputations , and episodes of secondary infection . RESULTS A total of 317 patients were r and omised . After 88 withdrawals , 229 remained evaluable . A greater proportion of smaller ( 25 - 100 mm(2 ) ulcers healed within the specified time ( 48.3 % versus 37.3 % ; p = 0.048 ) . There was , however , no difference between the three dressings in terms of percentage healed by 24 weeks , or in the mean time to healing , whether analysed on the basis of intention to treat ( Inadine 44.4 % , N-A 38.7 % , Aquacel 44.7 % ; not significant ) or per protocol ( Inadine 55.2 % , N-A 59.4 % , Aquacel 63.0 % ; not significant ) . There was no difference in the quality of healing , as reflected in the incidence of recurrence within 12 weeks . Likewise , there was no difference in the incidence of adverse events , although a greater proportion of those r and omised to the non-adherent dressings were withdrawn from the study ( 34.9 % versus 29.1 % Aquacel and 19.4 % Inadine ; p = 0.038 ) . The only statistically significant difference found in the health economic analysis was the cost associated with the provision of dressings ( mean cost per patient : N-A 14.85 pounds , Inadine 17.48 pounds , Aquacel 43.60 pounds ) . The higher cost of Aquacel was not offset by the fewer dressings required . There was no difference in measures of either generic or condition-specific measures of quality of life . However , there was a significant difference in the change in pain associated with dressing changes between the first and second visits , with least pain reported by those receiving non-adherent dressings ( p = 0.012 ) . There was no difference in the costs of professional time , and this may relate to the number of dressing changes undertaken by non-professionals . Fifty-one per cent of all participants had at least one dressing change undertaken by themselves or a non-professional carer , although this ranged from 22 % to 82 % between the different centres . CONCLUSIONS As there was no difference in effectiveness , there is no reason why the least costly of the three dressings could not be used more widely across the UK National Health Service , thus generating potentially substantial savings . The option of involving patients and non-professional carers in changing dressings needs to be assessed more formally and could be associated with further significant reductions in health-care costs . TRIAL REGISTRATION Current Controlled Trials IS RCT N78366977 Background Peripheral diabetic neuropathy affects between 20 % and 45 % of patients with diabetes . Objective To ascertain the effect of lacosamide on pain associated with peripheral diabetic neuropathy . Methods One hundred nineteen patients with a 1 to 5-year history of pain attributed to diabetic neuropathy and a score of ≥4 on the Likert pain scale entered the multicenter , r and omized , double-blind , placebo-controlled trial . Lacosamide ( N=60 ) titrated from 100 to 400 mg/d or maximum tolerated dose and placebo ( N=59 ) were the trial interventions . Primary efficacy criterion was change in pain score on the 11-point Likert pain scale . Secondary assessment s included Short-Form McGill Pain and Short-Form-36 Quality of Life Question naires , sleep/activity interference , pain intensity , Patient and Clinical Global Impression of Change , and Profile of Mood .  Patients receiving at least 1 dose of medication underwent safety evaluation . Results Ninety-four patients ( lacosamide 46 ; placebo 48 ) completed the trial . Lacosamide had significantly ( P=0.039 ) better pain relief  versus placebo ( primary outcome ) . Improvements were also seen in secondary outcome measures . Adverse events occurred in 52 lacosamide and 44 placebo patients . Common adverse events , occurring in ≥5 % of patients , were headache  ( lacosamide 18 % , placebo 22 % ) , dizziness  ( lacosamide 15 % , placebo 8 % ) , and nausea  ( lacosamide 12 % , placebo 7 % ) . Five lacosamide and 3 placebo patients withdrew for adverse events . Discussion Lacosamide seems to attenuate pain in diabetic neuropathy in doses up to 400 mg/d and improves quality of life issues OBJECTIVE —The purpose of this study was to determine the efficacy of anodyne monochromatic infrared photo energy ( MIRE ) in-home treatments over a 90-day period to improve peripheral sensation and self-reported quality of life in individuals with diabetes . RESEARCH DESIGN AND METHODS —This was a double-blind , r and omized , sham-controlled clinical trail . We r and omly assigned 69 individuals with diabetes and a vibration perception threshold ( VPT ) between 20 and 45 V to two treatment groups : active or sham treatment . Sixty patients ( 120 limbs ) completed the study .  Anodyne units were used at home every day for 40 min for 90 days . We evaluated nerve conduction velocities , VPT , Semmes-Weinstein monofilaments ( SWM ) ( 4- , 10- , 26- , and 60-g monofilaments ) , the Michigan Neuropathy Screening Instrument ( MNSI ) , a 10-cm visual analog pain scale , and a neuropathy-specific quality of life instrument . We used a nested repeated- measures multiple ANOVA design . Two sites ( great toe and fifth metatarsal ) were tested on both the left and right feet of each patient , so two feet were nested within each patient and two sites were nested within each foot . To analyze the ordinal SWM scores , we used a nonparametric factorial analysis for longitudinal data . RESULTS —There were no significant differences in measures for quality of life , MNSI , VPT , SWM , or nerve conduction velocities in active or sham treatment groups ( P > 0.05 ) . CONCLUSIONS —Anodyne MIRE therapy was no more effective than sham therapy in the treatment of sensory neuropathy in individuals with diabetes CONTEXT Peripheral neuropathy is one of the most common complications of diabetes . OBJECTIVES The purpose of this study was to evaluate the effects of photon stimulation on pain intensity , pain relief , pain qualities , sensation and quality of life ( QOL ) in patients with painful diabetic peripheral neuropathy . METHODS In this r and omized , placebo-controlled trial , patients were assigned to receive either four photon stimulations ( n=63 ) or four placebo ( n=58 ) treatments .  Pain intensity , pain relief , and pain qualities were assessed using self-report question naires . Sensation was evaluated using monofilament testing . QOL was measured using the Medical Outcomes Study Short Form-36 ( SF-36 ) . Multilevel regression model analyses were used to evaluate between-group differences in study outcomes . RESULTS No differences , over time , in any pain intensity scores ( i.e. , pain intensity immediately post-treatment , average pain , worst pain ) or pain relief scores were found between the placebo and treatment groups . However , significant decreases , over time , were found in some pain quality scores , and significant improvements in sensation were found in patients who received the photon stimulation compared with placebo . In addition , patients in the treatment group reported significant improvements in SF-36 social functioning and mental health scores . Findings from a responder analysis demonstrated that no differences were found in the percentages of patients in the placebo and treatment groups who received 30 % or more or 50 % or more reduction in pain scores immediately post-treatment . However , significant differences were found in the distribution of the changes in pain relief scores , with most of the patients in the photon stimulation group reporting a slight ( 28.6 % ) to moderate ( 34.9 % ) improvement in pain relief from the beginning to the end of the study compared with no change in pain relief ( 43.1 % ) in the placebo group . CONCLUSION Four treatments with photon stimulation result ed in significant improvements in some pain qualities , sensation , and QOL outcomes in a sample of patients with a significant amount of pain and disability from their diabetes . A longer duration study is needed to further refine the photon stimulation treatment protocol in these chronically ill patients and to evaluate the sustainability of its effects Abstract Objective : To calculate costs for the management of deep foot infections and to identify the most important factors related to treatment costs . Design : Costs for  in-hospital care , surgery , investigations , antibacterials  , visits to the foot-care team , orthopaedic appliances and topical treatment were calculated retrospectively from diagnosis until healing or death . Multiple regression analysis was used to identify factors that independently affect costs . Setting : A multidisciplinary foot-care team . Patients : 220 prospect ively followed patients with diabetes mellitus and deep foot infections who were referred to the team from 1986 to 1995 . Main Outcome Measures and Results : Total cost for healing without amputation was Swedish kronor (SEK)136 600 per patient , while the corresponding cost for healing with minor amputation was SEK260 000 and with major amputation was SEK234 500 . All costs were quoted in SEK at 1997 price levels ( £ 1 sterling and $ US1 equalled approximately SEK12.50 and SEK7.64 , respectively ) . The cost of antibacterials  was 4%of total costs . The cost of topical treatment was 51 
    Output:
    
Disease-specific tools were better than generic at quantifying temporal changes in life quality and showed greater sensitivity to ulcer/neuropathic severity .
Generic and utility  HRQOL  PROMs are frequently used as secondary outcome measures in r and omised trials and cost – utility analysis .HRQOL is depressed in diabetes , further impaired by the presence of foot disease .
Ulcer healing is associated with improvements in HRQOL .
Patients with active ulceration report poorer HRQOL than those whom have undergone successful minor lower extremity amputation ( LEA ) but there is a paucity of quality data on HRQOL outcomes for diabetes-related LEA .
Conclusions /interpretationNo one PROM was identified as a ‘ gold st and ard ’ for assessing HRQOL in diabetes-related foot disease .