{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T21:42:18Z","timestamp":1790718138435,"version":"4.1.0"},"reference-count":45,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2023,2,13]],"date-time":"2023-02-13T00:00:00Z","timestamp":1676246400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["International Wound Journal"],"published-print":{"date-parts":[[2023,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>A major obstacle to the development of new treatments for venous leg ulcers is the difficulty in generating evidence for their effectiveness. Randomised controlled trials using complete healing as the endpoint are seldom powered to be successful, owing to the heterogeneity of cohorts. A novel approach to the evaluation of treatments is presented, using a self\u2010controlled trial model and two metrics of short\u2010term healing rate as alternate endpoints: rate of wound margin advance, and percentage area reduction over 4\u2009weeks. Two different treatment regimens are compared: multi\u2010layer compression alone, versus multi\u2010layer compression combined with activation of the venous leg pump by neuromuscular stimulation. With 60 patients, adding neuromuscular stimulation to multilayer compression resulted in a significant two\u2010fold increase in the rate of wound healing over a 4\u2010week period, both in terms of wound margin advance and in terms of percentage area reduction. The use of these short\u2010term intermediate endpoint metrics together with a self\u2010controlled study design offers potential for distinguishing between the relative efficacies of interventions more rapidly, with greater sensitivity, and with fewer subjects than a conventional RCT cohort model.<\/jats:p>","DOI":"10.1111\/iwj.14107","type":"journal-article","created":{"date-parts":[[2023,2,14]],"date-time":"2023-02-14T02:52:45Z","timestamp":1676343165000},"page":"2260-2268","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["The impact of a new intervention for venous leg ulcers: A within\u2010patient controlled trial"],"prefix":"10.1111","volume":"20","author":[{"given":"Richard Hillson","family":"Bull","sequence":"first","affiliation":[{"name":"Accelerate CIC, Centenary Wing St Joseph's Hospice  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2318-1575","authenticated-orcid":false,"given":"Donna","family":"Clements","sequence":"additional","affiliation":[{"name":"CRN Eastern, Norfolk Community Health and Care Trust  Norwich UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agnes Juguilon","family":"Collarte","sequence":"additional","affiliation":[{"name":"North West Division (Central London, Hammersmith &amp; Fulham and West London) St Charles Centre for Health &amp; Wellbeing  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith Gordon","family":"Harding","sequence":"additional","affiliation":[{"name":"WWII Ltd (Welsh Wound Innovation Initiative), Welsh Wound Innovation Centre  Pontyclun UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,2,13]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2015-009283"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.13848"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.21650"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/0190-9622(91)70295-D"},{"key":"e_1_2_10_6_1","first-page":"1902","article-title":"Venous leg ulcers","volume":"2016","author":"Nelson EA","year":"2016","journal-title":"BMJ Clin Evid"},{"issue":"28","key":"e_1_2_10_7_1","article-title":"Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity","volume":"3","author":"Godwin M","year":"2003","journal-title":"BMC Med Res Methodol"},{"issue":"1","key":"e_1_2_10_8_1","first-page":"33\u2009S","article-title":"Care of venous ulcers","volume":"45","author":"Falanga V","year":"1999","journal-title":"Ostomy Wound Manage"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/archsurg.135.7.773"},{"issue":"11","key":"e_1_2_10_10_1","article-title":"Compression for venous leg ulcers","volume":"11","author":"O'Meara S","year":"2012","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1523-1747.2002.19629.x"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.12533"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM198401053100106"},{"key":"e_1_2_10_14_1","unstructured":"AdvaMed Wound Healing and Tissue Regeneration Sector.Guiding Principles for Clinical Research in Chronic Wound Healing: A Consensus Document.2010."},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jccw.2016.07.002"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.13669"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0031-1278361"},{"key":"e_1_2_10_18_1","volume-title":"Simplifying Venous Leg Ulcer Management. 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