{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T14:31:16Z","timestamp":1791815476513,"version":"4.3.4"},"reference-count":188,"publisher":"National Institute for Health and Care Research","issue":"57","license":[{"start":{"date-parts":[[2014,9,1]],"date-time":"2014-09-01T00:00:00Z","timestamp":1409529600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000276","name":"National Institute for Health Research","doi-asserted-by":"publisher","award":["07\/60\/26"],"award-info":[{"award-number":["07\/60\/26"]}],"id":[{"id":"10.13039\/501100000276","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"Background<\/jats:title>Compression is an effective and recommended treatment for venous leg ulcers. Although the four-layer bandage (4LB) is regarded as the gold standard compression system, it is recognised that the amount of compression delivered might be compromised by poor application technique. Also the bulky nature of the bandages might reduce ankle or leg mobility and make the wearing of shoes difficult. Two-layer compression hosiery systems are now available for the treatment of venous leg ulcers. Two-layer hosiery (HH) may be advantageous, as it has reduced bulk, which might enhance ankle or leg mobility and patient adherence. Some patients can also remove and reapply two-layer hosiery, which may encourage self-management and could reduce costs. However, little robust evidence exists about the effectiveness of two-layer hosiery for ulcer healing and no previous trials have compared two-layer hosiery delivering \u2018high\u2019 compression with the 4LB.<\/jats:p><\/jats:sec>Objectives<\/jats:title>Part I<\/jats:italic>\u2002To compare the clinical effectiveness and cost-effectiveness of HH and 4LB in terms of time to complete healing of venous leg ulcers.Part II<\/jats:italic>\u2002To synthesise the relative effectiveness evidence (for ulcer healing) of high-compression treatments for venous leg ulcers using a mixed-treatment comparison (MTC).Part III<\/jats:italic>\u2002To construct a decision-analytic model to assess the cost-effectiveness of high-compression treatments for venous leg ulcers.<\/jats:p><\/jats:sec>Design<\/jats:title>Part I<\/jats:italic>\u2002A multicentred, pragmatic, two-arm, parallel, open randomised controlled trial (RCT) with an economic evaluation.Part II<\/jats:italic>\u2002MTC using all relevant RCT data \u2013 including Venous leg Ulcer Study IV (VenUS IV).Part III<\/jats:italic>\u2002A decision-analytic Markov model.<\/jats:p><\/jats:sec>Settings<\/jats:title>Part I<\/jats:italic>\u2002Community nurse teams or services, general practitioner practices, leg ulcer clinics, tissue viability clinics or services and wound clinics within England and Northern Ireland.<\/jats:p><\/jats:sec>Participants<\/jats:title>Part I<\/jats:italic>\u2002Patients aged \u2265\u200918 years with a venous leg ulcer, who were willing and able to tolerate high compression.<\/jats:p><\/jats:sec>Interventions<\/jats:title>Part I<\/jats:italic>\u2002Participants in the intervention group received HH. The control group received the 4LB, which was applied according to standard practice. Both treatments are designed to deliver 40\u2009mmHg of compression at the ankle.Part II and III<\/jats:italic>\u2002All relevant high-compression treatments including HH, the 4LB and the two-layer bandage (2LB).<\/jats:p><\/jats:sec>Main outcome measures<\/jats:title>Part I<\/jats:italic>\u2002The primary outcome measure was time to healing of the reference ulcer (blinded assessment).Part II<\/jats:italic>\u2002Time to ulcer healing.Part III<\/jats:italic>\u2002Quality-adjusted life-years (QALYs) and costs.<\/jats:p><\/jats:sec>Results<\/jats:title>Part I<\/jats:italic>\u2002A total of 457 participants were recruited. There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis [hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.79 to 1.25;p<\/jats:italic>\u2009=\u20090.96]. Time to ulcer recurrence was significantly shorter in the 4LB group (HR\u2009=\u20090.56, 95% CI 0.33 to 0.94;p<\/jats:italic>\u2009=\u20090.026). In terms of cost-effectiveness, using QALYs as the measure of benefit, HH had a >\u200995% probability of being the most cost-effective treatment based on the within-trial analysis.Part II<\/jats:italic>\u2002The MTC suggests that the 2LB has the highest probability of ulcer healing compared with other high-compression treatments. However, this evidence is categorised as low to very low quality.Part III<\/jats:italic>\u2002Results suggested that the 2LB had the highest probability of being the most cost-effective high-compression treatment for venous leg ulcers.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>Trial data from VenUS IV found no evidence of a difference in venous ulcer healing between HH and the 4LB. HH may reduce ulcer recurrence rates compared with the 4LB and be a cost-effective treatment. When all available high-compression treatments were considered, the 2LB had the highest probability of being clinically effective and cost-effective. However, the underpinning evidence was sparse and more research is needed. Further research should thus focus on establishing, in a high-quality trial, the effectiveness of this compression system in particular.<\/jats:p><\/jats:sec>Trial registration<\/jats:title>Current Controlled Trials ISRCTN49373072.<\/jats:p><\/jats:sec>Funding<\/jats:title>This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment<\/jats:italic>; Vol. 18, No. 57. See the NIHR Journals Library website for further project information.<\/jats:p><\/jats:sec>","DOI":"10.3310\/hta18570","type":"journal-article","created":{"date-parts":[[2014,9,23]],"date-time":"2014-09-23T08:19:10Z","timestamp":1411460350000},"page":"1-294","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":71,"title":["VenUS IV (Venous leg Ulcer Study IV) \u2013 compression hosiery compared with compression bandaging in the treatment of venous leg ulcers: a randomised controlled trial, mixed-treatment comparison and decision-analytic model"],"prefix":"10.3310","volume":"18","clinical-trial-number":[{"clinical-trial-number":"isrctn49373072","registry":"10.18810\/isrctn","type":"results"}],"author":[{"given":"Rebecca L","family":"Ashby","sequence":"first","affiliation":[{"name":"Department of Health Sciences, The University of York, York, 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