{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T06:47:28Z","timestamp":1773298048559,"version":"3.50.1"},"reference-count":23,"publisher":"BMJ","issue":"7","license":[{"start":{"date-parts":[[2020,7,19]],"date-time":"2020-07-19T00:00:00Z","timestamp":1595116800000},"content-version":"unspecified","delay-in-days":18,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001505","name":"Health Research Council of New Zealand","doi-asserted-by":"publisher","award":["16\/135"],"award-info":[{"award-number":["16\/135"]}],"id":[{"id":"10.13039\/501100001505","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2020,6,4]]},"published-print":{"date-parts":[[2020,7]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To determine the effect of a keratin dressing for treating slow-to-heal venous leg ulcers (VLU) on VLU healing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Pragmatic parallel group randomised controlled trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Community-dwelling participants.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>\n                      People aged 18 or more years with VLU (either present for more than 26 weeks or ulcer area larger than 5 cm\n                      <jats:sup>2<\/jats:sup>\n                      or both).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>Wool-derived keratin dressing or usual care formulary of non-medicated dressings, on a background treatment with compression.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary and secondary outcome measures<\/jats:title>\n                    <jats:p>Healing at 24 weeks based on blinded assessment of ulcer photographs. Other outcomes included time to complete healing, change in ulcer area to 24 weeks, change in health-related quality of life and incidence of adverse events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      We screened 1068 patients with VLU and randomised 143 participants (51.1% of target recruitment), 71 to the keratin dressing group and 72 to the usual care group.The mean age was 66.1 years (SD 15.9) and 53 participants (37.1%) were women. There were no significant differences between the groups on the primary outcome (risk difference \u22126.4%, 95% CI \u221222.5% to 9.7%), change in ulcer area (\u22121.9 cm\n                      <jats:sup>2<\/jats:sup>\n                      , 95% CI \u221216.5 to 12.8 cm\n                      <jats:sup>2<\/jats:sup>\n                      ), time to complete healing (HR 0.80, 95% CI 0.52 to 1.23) or the incidence of adverse events (incidence rate ratio 1.19, 95% CI 0.89 to 1.59) in the intention-to-treat analyses. However, the direction of effect on the primary outcome was reversed in a per protocol analysis specified a priori (risk difference 6.2%, 95% CI \u221212.4% to 24.9%).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The effect of adding a keratin dressing to the treatment regimen for prognostically slow-to-heal VLU remains unclear.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial results\" xlink:href=\"NCT02896725\">NCT02896725<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2019-036476","type":"journal-article","created":{"date-parts":[[2020,7,21]],"date-time":"2020-07-21T02:05:55Z","timestamp":1595297155000},"page":"e036476","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":9,"title":["Wool-derived keratin dressings versus usual care dressings for treatment of slow healing venous leg ulceration: a randomised controlled trial (Keratin4VLU)"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct02896725","registry":"10.18810\/clinical-trials-gov","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8484-3771","authenticated-orcid":false,"given":"Andrew","family":"Jull","sequence":"first","affiliation":[{"name":"School of Nursing, University of Auckland, Auckland, Auckland, New Zealand"},{"name":"National Institute for Health Innovation, University of Auckland, Auckland, New Zealand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angela","family":"Wadham","sequence":"additional","affiliation":[{"name":"National Institute for Health Innovation, University of Auckland, Auckland, New Zealand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chris","family":"Bullen","sequence":"additional","affiliation":[{"name":"National Institute for Health Innovation, University of Auckland, Auckland, New Zealand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Varsha","family":"Parag","sequence":"additional","affiliation":[{"name":"National Institute for Health Innovation, University of Auckland, Auckland, New Zealand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8016-1060","authenticated-orcid":false,"given":"Carolina","family":"Weller","sequence":"additional","affiliation":[{"name":"School of Nursing and Midwifery, Monash University, Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jill","family":"Waters","sequence":"additional","affiliation":[{"name":"Hope Foundation for Research on Ageing, Auckland, New Zealand"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2020,7,20]]},"reference":[{"key":"2025121409305567000_10.7.e036476.1","doi-asserted-by":"publisher","DOI":"10.1042\/BC20040098"},{"key":"2025121409305567000_10.7.e036476.2","doi-asserted-by":"publisher","DOI":"10.1089\/wound.2013.0473"},{"key":"2025121409305567000_10.7.e036476.3","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2008.07.018"},{"key":"2025121409305567000_10.7.e036476.4","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0625.2012.01505.x"},{"key":"2025121409305567000_10.7.e036476.5","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-475X.2012.00768.x"},{"key":"2025121409305567000_10.7.e036476.6","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9343(00)00379-X"},{"key":"2025121409305567000_10.7.e036476.7","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.b773"},{"key":"2025121409305567000_10.7.e036476.8","doi-asserted-by":"crossref","unstructured":"Watson JM , Kang\u2019ombe AR , Soares MO , et al . 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