***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: BACKGROUND The treatment of chronic leg ulcers  remains a stubborn problem in many patients . Topical 2 % ketanserin ointment , a 5HT2-serotoninergic blocking agent , has been reported to improve healing of decubitus , venous , diabetic and ischaemic ulcers . METHOD The present double-blind intra-individual comparative study was performed in 12 women with diabetes presenting with at least two similar leg ulcers . In each subject , the two lesions were r and omly assigned to be treated for 8 weeks by 2 % ketanserin ointment or its unmedicated vehicle . OBJECTIVE assessment s of the dynamics of wound healing were performed using computerized morphometry . Evaluations were performed at 2-week intervals for 8 weeks . RESULTS A significant decrease in relative wound area was observed on the ketanserin-treated ulcers compared with the placebo group . CONCLUSION Topical ketanserin is a valuable therapy for difficult-to-treat leg ulcers OBJECTIVE : A r and omized controlled trial to evaluate the effectiveness of a polyhexamethylene biguanide ( PHMB ) foam dressing compared with a similar non-antimicrobial foam for the treatment of  superficial bacterial burden , wound-associated pain , and reduction in wound size . SETTING AND PARTICIPANTS : This study was conducted in 2 wound healing clinics-a university hospital-based clinic and a community-based clinic . Forty-five chronic wound subjects , stratified to either foot or leg ulcers , were followed for 5 weeks . METHODS : A multicenter , prospect i ve , double-blind , pilot , r and omized controlled clinical trial with 3 study visits ( Weeks 0 , 2 , 4 ) documented pain and local wound characteristics using NERDS and STONEES clinical criteria to determine superficial bacterial damage or deep/surrounding infection . RESULTS : The use of PHMB foam dressing was a significant predictor of reduced wound superficial bacterial burden ( P = .016 ) at week 4 as compared with the foam alone . Pain reduction was also statistically significant at week 2 ( P = .0006 ) and at week 4 ( P = .02 ) in favor of the PHMB foam dressings . Polymicrobial organisms were recovered at week 4 in 5.3 % in the PHMB foam dressing group versus 33 % in the control group ( P = .04 ) . Subjects r and omized to the PHMB foam dressing had a 35 % median reduction in wound size by week 4 , compared with 28 % in the control group . CONCLUSIONS : PHMB foam dressing successfully reduced chronic wound pain and bacterial burden Chronic skin ulcers such as diabetic ulcers and venous leg ulcers are increasing and are a costly problem in healthcare . We have developed a novel artificial dermis , collagen/gelatin sponge ( CGS ) , which is capable of sustained release of basic fibroblast growth factor ( bFGF ) for more than 10 days . The objective of this study was to investigate the safety and efficacy of CGS impregnated with bFGF in the treatment of  chronic skin ulcers . Patients with chronic skin ulcers that had not healed in at least 4 weeks were treated with CGS impregnated with bFGF at 7 or 14 μg/cm(2 ) after debridement , and the wound bed improvement was assessed 14 days after application . Wound bed improvement was defined as a granulated and epithelialized area on day 14 with a proportion to the baseline wound area after debridement of 50 % or higher . The wound area , the wound area on day 14 , and the granulation area on day 14 were independently measured by blinded review ers in a central review using digital images of wounds taken with a calibrator . Patients were followed up until 28 days after application to observe the adverse reactions related to the application of CGS . From May 2010 to June 2011 , 17 patients were enrolled and , in 16 patients , the wound bed improved . Among the r and omized patients in step 2 , no significant difference was seen between the low-dose group and the high-dose group . No serious adverse reactions were observed . Adverse reactions with a clear causal relationship to the study treatment were mild and patients quickly recovered from them . This study is the first-in-man clinical trial of CGS and showed the safety and efficacy of CGS impregnated with bFGF in the treatment of chronic skin ulcers . This combination therapy could be a promising therapy for chronic skin ulcers OBJECTIVE To assess whether topical morphine is pharmacologically effective in relieving pain from ulcers caused by arterial insufficiency and identify whether this effect is central ly or peripherally mediated . METHOD The analgesic effect of a topically applied hydrogel containing 0.5 % of morphine was evaluated in a double-blind , placebo-controlled , three-way crossover pilot study involving nine patients with painful arterial leg ulcers . All patients had a baseline pain intensity of at least 5 on a 10-point numeric rating scale . They received the following three treatments in r and om order : morphine hydrogel plus a subcutaneous ( SC ) placebo infusion ; placebo gel plus a SC infusion of 5 mg morphine over six hours and a placebo gel plus a SC placebo infusion . Each treatment lasted one day . Pain was assessed during the first 24 hours after application of the hydrogel and the start of the subcutaneous infusion . RESULTS There was a statistically significant difference between average baseline pain scores and those reported during treatment , but this difference was not clinical ly relevant . The three treatments did not differ in terms of the pain relief provided . CONCLUSION Topical morphine does not have a clinical ly relevant analgesic effect in patients with painful arterial leg ulcers . Further research should focus on ulcers of other aetiology OBJECTIVE To determine the healing effect of topical becaplermin gel vs hydrogel dressing on hypertensive leg ulcers . DESIGN R and omized , double-blind , parallel-assignment , controlled study . SETTING Ambulatory or hospitalized patients from 17 dermatology departments . PATIENTS Among 64 consecutive r and omized patients with 1 or more hypertensive leg ulcers who fulfilled all inclusion criteria , 59 received the allocated intervention , and findings were analyzed . INTERVENTION Becaplermin gel ( human recombinant platelet-derived growth factor-BB , 0.1 % , in hydrogel ) or hydrogel dressing was applied , both in doses of 1 cm/cm(2 ) , once daily for 8 weeks . Follow-up continued for 4 weeks beyond the final gel application . MAIN OUTCOME MEASURES The primary end point was complete wound closure rate after 8 weeks of treatment . Secondary end points were percentages of patients with complete wound closure at week 12 ; changed ulcer area after treatment vs baseline ; and changed ulcer-related pain and health-related quality of life during the study . RESULTS Complete wound closure rates were comparable after 8 weeks for becaplermin ( 5 of 28 patients ) and hydrogel ( 3 of 31 patients ) ( 8 percentage-point difference ; 95 % confidence interval , -10 % to 26 % ) . No statistically significant differences were observed between the 2 groups for percentages of complete closure at week 12 , changed ulcer area at week 8 , or changed ulcer-related pain and quality of life during the study ( P > .05 for all comparisons ) . CONCLUSIONS Topical becaplermin gel is not superior to hydrogel dressing for hypertensive leg ulcer wound closure . Surgical management by grafting remains the most promising treatment strategy but requires further evaluation . Trial Registration clinical trials.gov Identifier : NCT00970697 BACKGROUND Elase is a widely used ointment consisting of a combination of 2 proteolytic enzymes , fibrinolysin and desoxyribonuclease ( DNAse ) . It is said to promote debridement of necrotic and purulent debris from skin ulcers . OBJECTIVE Our purpose was to assess the efficacy and safety of this ointment and its components in the treatment of chronic ulcers of the lower extremity . METHODS This was a double-blind , r and omized , prospect i ve study of 84 patients with leg ulcers exhibiting necrotic and purulent debris , who were treated for 21 days with twice-daily applications of the ointment , fibrinolysin , DNAse , or who received the ointment vehicle ( placebo ) . We assessed 6 efficacy features : ulcer size , purulent exu date , necrotic tissue , erythema , pain , and overall condition of the lesion at days 8 , 15 , and 21 after initiation of treatment . We also assessed the frequency of adverse effects . RESULTS All treatments produced some improvement in the efficacy parameters and overall condition of the ulcers by week 3 , but no statistically significant difference was found when compared with placebo . No serious adverse effects were noted . A later retrospective re analysis of the data found a statistically significant reduction of purulent exu date only at days 3 and 7 of treatment in the group treated with the complete ointment , but not in the other features . CONCLUSION The proteolytic ointment provides no long-term clinical benefit in reducing purulent exu date , pain , erythema , necrotic tissue , or overall condition of chronic leg ulcers when compared with either of its two components or placebo OBJECTIVE To evaluate the performance ( efficacy , safety and acceptability ) of a new micro-adherent absorbent dressing ( UrgoClean ® ) compared with a hydrofiber dressing ( Aquacel ® ) in the local management of venous leg ulcers , in the debridement stage . METHOD A non-inferiority European r and omised controlled clinical trial ( RCT ) was conducted in 37 centres , on patients presenting with venous or predominantly venous , mixed aetiology leg ulcers at their sloughy stage ( with more than 70 % of the wound bed covered with slough at baseline ) . Patients were followed over a 6-week period and assessed weekly . The primary judgement criteria was the relative regression of the wound surface area after the 6-week treatment period . Secondary endpoints were the relative reduction of sloughy tissue and the percentage of patients presenting with a debrided wound . RESULTS Altogether , 159 patients were r and omised to either UrgoClean ( test group ; n=83 ) or Aquacel ( control group ; n=76 ) dressings . Regarding the wound healing process predictive factors ( wound area , duration , ABPI value , recurrence ) , at baseline , the two groups were well balanced , for both wound and patient characteristics . Compression therapy was administered to both groups and after a median 42-day treatment period , the percentage of relative reduction of the wound surface area was very similar ( -36.9 % vs -35.4 % in the UrgoClean and control groups , respectively ) . When considering the secondary criteria at week 6 , the relative reduction of sloughy tissue was significantly higher in the UrgoClean group than in the control group ( -65.3 % vs -42,6 % ; p=0.013 ) . The percentage of debrided wounds was also significantly higher in the test group ( 52.5 % vs 35.1 % ; p=0.033 ) . CONCLUSION This ' EARTH ' RCT confirmed that the UrgoClean dressing has similar efficacy and safety compared to Aquacel . However , UrgoClean also showed better autolytic properties than the control group in the management of venous leg ulcers at the sloughy stage . The new UrgoClean dressing therefore represents a promising therapeutic option within the current range of autolytic dressings available . DECLARATION OF INTEREST This study was sponsored by a grant from the pharmaceutical company Laboratoires Urgo . S. Bohbot and O. Tacca are employees of Laboratoires Urgo . S. Meaume , J. Dissemond and G. Perceau have received monetary compensation as presenters for Laboratoires Urgo . Data management and statistical analyses were conducted independently by Vertical ( Paris , France ) Abstract Aims / Introduction Dysregulated inflammatory response is believed to be an important factor in the pathogenesis of several late complications of diabetes mellitus . β‐Glucans are potent inducers of immune function . The present r and omized , double blind , two‐center , placebo‐controlled study was undertaken to explore safety , tolerability and efficacy of soluble β‐1,3/1,6‐glucan ( SBG ) as a local treatment of diabetic foot ulcers . Material s and Methods A total of 60 patients with type 1 or 2 diabetes and lower extremity ulcers ( Wagner grade 1–2 , Ankle/Brachial Index ≥0.7 ) received SBG or a comparator product ( methylcellulose ) locally three times weekly up to 12 weeks in addition to conventional management scheme . A total of 54 patients completed the study . Results A tendency for shorter median time to complete healing in the SBG group was observed ( 36 vs 63 days , P = 0.130 ) . Weekly percentage reduction in ulcer size was significantly higher in the SBG group than in the methylcellulose group between weeks 1–2 , 3–4 and 5–6 ( P < 0.05 ) . The proportion of ulcers healed by week 12 was also in favor of SBG ( 59 % vs 37 % , P = 0.09 ) , with a significantly higher healing incidence in the SBG group at week 8 ( 44 % vs 17 % ,  P = 0.03 ) . SBG  was safe and well tolerated . There was a clinical ly significant difference regarding the incidence of serious adverse events in favor of the 
    Output:
    
There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers