***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: OBJECTIVE To test the safety , efficacy , and immunological impact of a cultured allogeneic human skin equivalent ( HSE ) in the treatment of venous ulcers . DESIGN Prospect i ve , r and omized study . SETTING Multicenter study in the outpatient setting . INTERVENTION Each patient with a venous ulcer received either compression therapy alone or compression therapy and treatment with HSE . The patients were evaluated for  HSE safety , complete ( 100 % ) ulcer healing , time to wound closure , wound recurrence , and immune response to the HSE .  OUTCOME The study was completed as planned in 293 r and omized patients . RESULTS Treatment with HSE was more effective than compression therapy in the percentage of patients healed by 6 months ( 63 % vs 49 % ; P=.02 , Fisher exact test , 2-tailed ) and the median time to complete wound closure ( 61 days vs 181 days ; P=.003 , log-rank test ) . Treatment with HSE was superior to compression therapy in healing larger ( > 1000 mm2 ; P=.02 ) and deeper ulcers ( P=.003 ) and ulcers of more than 6 months ' duration ( P=.001 ) . Occurrence of adverse events was similar in both groups . No symptoms or signs of rejection occurred in response to treatment with HSE , and no  HSE-specific immune responses were detected in vitro to bovine collagen or to alloantigens expressed on keratinocytes or fibroblasts . CONCLUSIONS Treatment with HSE healed venous ulcers more rapidly and in more patients than compression therapy alone . There was no clinical or laboratory evidence of rejection or sensitization in response to HSE application . These data suggest that HSE represents a significant advance in the treatment of venous ulcers , particularly those that are difficult to heal In a prospect i ve study , 314 patients with diabetic foot ulcers were followed and 40 patients died before healing occurred . In those patients who healed , a retrospective economic analysis of the costs for topical treatment was performed . The aim of the study was to analyse the costs and discuss how different treatment strategies influence total costs . Data collected for each patient were total time to healing , treatment time for each type of dressing , and the frequency of dressing changes . Material costs for the dressings , labour , and travelling costs were calculated separately . A formula for simulation of economic consequences of different treatment strategies including the introduction of new strategies was design ed . The cost for  topical treatment  was strongly related to the severity of the ulcer and wound healing time . The average weekly cost per patient for topical treatment varied between 40.3 pounds and 385 pounds . The dominating costs for topical treatment were expenses for staff and transportation . The most important factor to reduce costs is the frequency of dressing changes . The study emphasizes the need for prospect i ve comparative studies of cost effectiveness in topical treatment strategies OBJECTIVE We assessed in a r and omized prospect i ve trial the effectiveness of Graftskin , a living skin equivalent , in treating noninfected nonischemic chronic plantar diabetic foot ulcers . RESEARCH DESIGN AND METHODS In 24 centers in the U.S. , 208 patients were r and omly assigned to ulcer treatment either with Graftskin ( 112 patients ) or saline-moistened gauze ( 96 patients , control group ) .  St and ard state-of-the-art adjunctive therapy , which included extensive surgical debridement and adequate foot off-loading , was provided in both groups . Graftskin was applied at the beginning of the study and weekly thereafter for a maximum of 4 weeks ( maximum of five applications ) or earlier if complete healing occurred . The major outcome of complete wound healing was assessed by intention to treat at the 12-week follow-up visit . RESULTS At the 12-week follow-up visit , 63 ( 56 % ) Graftskin-treated patients achieved complete wound healing compared with 36 ( 38 % ) in the control group ( P = 0.0042 ) . The Kaplan-Meier median time to complete closure was 65 days for Graftskin , significantly lower than the 90 days observed in the control group ( P = 0.0026 ) . The odds ratio for complete healing for a Graftskin-treated ulcer compared with a control-treated ulcer was 2.14 ( 95 % CI 1.23 - 3.74 ) . The rate of adverse reactions was similar between the two groups with the exception of osteomyelitis and lower-limb amputations , both of which were less frequent in the Graftskin group . CONCLUSIONS Application of Graftskin for a maximum of 4 weeks results in a higher healing rate when compared with state-of-the-art currently available treatment and is not associated with any significant side effects . Graftskin may be a very useful adjunct for the management of diabetic foot ulcers that are resistant to the currently available st and ard of care OBJECTIVE To compare the efficacy and safety of topically applied recombinant human platelet-derived growth factor-BB ( rhPDGF-BB ) ( becaplermin ) with placebo gel in patients with chronic diabetic neuropathic ulcers of the lower extremities . RESEARCH DESIGN AND METHODS This multicenter double-blind placebo-controlled phase 111 trial included 382 patients with type 1 or type 2 diabetes and chronic ulcers of at least 8 weeks ' duration . After sharp debridement of the ulcer , patients were r and omized to receive becaplermin gel 30 μg/g , becaplermin gel 100 μg/g , or placebo gel , in conjunction with a st and ardized regimen of good wound care until complete wound closure was achieved or for a maximum of 20 weeks . Moist saline-soaked gauze dressings were changed twice daily with study medication applied by patients or caregivers at the evening dressing change . Safety was assessed by monitoring adverse events ( AEs ) and by clinical laboratory evaluations . RESULTS Compared with placebo gel , becaplermin gel 100 μg/g significantly increased the incidence of complete wound closure by 43 % ( 50 vs. 35 % , P = 0.007 ) and decreased the time to achieve complete wound closure by 32 % ( 86 vs. 127 days ; estimated 35th percentile , P = 0.013 ) . AEs reported during treatment or during a 3-month follow-up period were similar in nature and incidence across all treatment groups . CONCLUSIONS Becaplermin gel 100 μg/g , in conjunction with good wound care , significantly increased the incidence of complete wound closure and significantly reduced the time to complete closure of chronic diabetic neuropathic ulcers . The safety profile of becaplermin gel was similar to that of placebo gel Introduction : The effect on quality of life by healing leg ulcers is not known and no vali date d disease-specific tool is available for measuring health-related quality of life ( HRQoL ) for people with venous leg ulcers . The objective of this paper was to compare four generic instruments [ MOS 36-Item Short-Form Health Survey ( SF-36 ) ; EuroQol ( EQ ) ; McGill Short Form Pain Question naire ( SF-MPQ ) and the  Frenchay Activities Index ( FAI ) ] used for measuring HRQoL in people with venous leg ulcers , and to offer guidance on the most appropriate tool for research ers . Methods : Two hundred and thirty-three patients with venous leg ulcers were recruited as part of a r and omised controlled trial of the cost-effectiveness of community leg ulcer clinics . Subjects completed question naires containing the four instruments on three occasions ( initial assessment , 3 and 12 months ) . The discriminative and evaluative properties of the four instruments were compared . Results : All four instruments were acceptable to patients , taking a mean of 19.3 ( SD 6.3 ) min to complete . At initial assessment , the SF-MPQ had poorer discriminative properties than the other three instruments and was not able to distinguish between the different patient groups in relation to age and ulcer duration . The FAI was good at discriminating between the different patient groups ( at initial assessment ) in relation to age , mobility and ulcer size . At the three-month follow-up , the SF-MPQ was more responsive than the other measures and detected changes in HRQoL , whereas the EQ and SF-36 did not . At 12 months , the SF-MPQ still identified differences and the SF-36 and EQ also did at this stage . Conclusion : In the absence of a vali date d condition-specific tool for measuring changes in general health status for patients with venous leg ulcers , we make the following recommendations . For evaluating the outcome of interventions with a short-term follow-up ( three months ) in a clinical study we recommend the SF-MPQ and for 12-month follow-up in a clinical study the SF-36 , with or without the SF-MPQ The results of four multicenter , r and omized , placebo-controlled , parallel group studies of the efficacy of becaplermin gel are review ed here . The four studies included a total of 922 patients , all of whom received a st and ardized regimen of good ulcer care . Patients were r and omized to receive placebo gel , 30 or 100 microg/g becaplermin gel , or good ulcer care alone . In Studies 1 and 2 , the incidence of complete healing was significantly higher in patients receiving becaplermin gel ( 30 microg/g , Study 1 ; 100 microg/g , Study 2 ) compared with that in patients receiving placebo gel . In Study 3 , which was not powered for statistical analysis , the incidence of complete healing in patients treated with 100 microg/g becaplermin gel was approximately twice that of patients treated with good ulcer care alone . In Study 4 , there was no significant difference in the incidence of complete healing in patients treated with becaplermin gel versus good ulcer care alone The purpose of this study was to analyze long-term costs for foot ulcers in diabetic patients . Patients were treated and followed prospect ively by a foot care team . A retrospective economic analysis was performed of costs for 274 patients during 3 years from healing of an initial foot ulcer , with or without amputation . Costs were estimated for inpatient care , outpatient care , home care , and social service . The cost calculations include costs due to complications and disability related to the initial ulcer , costs related to recurrence of ulcer , and costs for prevention of new ulcers . Expected total present value cost per patient during 3 years of observation was $ 26,700 ( U.S. dollars ) for primary healed patients with critical ischemia and $ 16,100 for primary healed patients without critical ischemia . For patients who healed with an amputation , the corresponding costs were $ 43,100 after a minor amputation and $ 63,100 after a major amputation . When estimating the costs for diabetic foot ulcers , it is not sufficient to calculate short-term costs . Long-term costs are high , mainly due to the need for increased home care and social service , but also due to costs for recurrent ulcers and new amputations The results of a combined analysis and separate analyses of four multicenter , r and omized , parallel group studies that evaluated the effects of once-daily topical administration of becaplermin gel for the treatment of chronic , full thickness , lower extremity diabetic ulcers are presented . The four studies included a total of 922 patients with nonhealing lower extremity diabetic ulcers of at least 8 weeks ' duration . Following initial complete sharp debridement of the ulcer , patients were r and omized to receive a st and ardized regimen of good ulcer care alone , good ulcer care plus placebo gel , or good ulcer care plus becaplermin gel-30 microg/g , or good ulcer care plus becaplermin gel-100 microg/g , with various combinations of regimens used in the four studies . Safety was assessed by monitoring adverse events and by clinical laboratory evaluations . Meta-analytic statistical techniques were used in the combined analysis to establish homogeneity of treatment comparisons across studies . Based on an analysis of patients with baseline ulcer area common to all trials ( < /= 10 cm2 ) , representing 95 % of all patients , becaplermin gel-100 microg/g significantly increased ( p = 0.007 ) the probability of complete healing compared with placebo gel . It was determined that for the median ulcer area of these patients , which was 1.5 cm2 , the becaplermin gel-100 microg/g treatment group showed a 39 % increase in complete healing compared with that of the placebo gel treatment group ( 50 % vs. 36 % , respectively , p = 0.007 ) . Becaplermin gel-100 microg/g significantly decreased ( p = 0.01 ) the time to complete healing compared with placebo gel , with the 35th percentile of time to complete healing being reduced by 30 % ( 14.1 weeks vs. 20 . 1 weeks , respectively ) . In patients with ulcers < /= 5 cm2 at baseline ( a more homogeneous group ) , becaplermin gel-100 microg/g also significantly increased the incidence of complete healing with a similar decrease in the time to healing . Adverse events reported during treatment or during a 3-month follow-up period were not unexpected for this patient population and were similar in nature and incidence across all treatment groups . We therefore conclude that treatment with becaplermin gel at a dose of 100 microg/g once daily , in conjunction with good ulcer care , is effective and well tolerated in patients with full thickness lower extremity diabetic ulcers OBJECTIVES The objective of this study was to develop a model capable of assessing the cost-effectiveness in Sweden of treating diabetic neuropathic lower extremity ulcers with becaplermin gel ( Regranex ) plus good wound care ( GWC ) relative to treating them with GWC alone . METHO 
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They calculated that due to shorter treatment periods , fewer complications and fewer inpatient episodes the initial cost of the novel biotechnology products may be offset , making the treatment cost-effective or even cost-saving .
Conclusion The study results suggest that some growth factors and tissue-engineered artificial skin products feature favourable cost-effectiveness ratios in selected patient groups with chronic wounds .