{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,12]],"date-time":"2026-06-12T00:28:30Z","timestamp":1781224110301,"version":"3.54.1"},"reference-count":32,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2021,11,6]],"date-time":"2021-11-06T00:00:00Z","timestamp":1636156800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Inotec AMD Ltd"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["The International Journal of Lower Extremity Wounds"],"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:p>\n                    Natrox\n                    <jats:sup>\u2122<\/jats:sup>\n                    topical oxygen therapy (TOT) ( Inotec AMD Ltd, Cambridgeshire, UK) employs a small battery-powered \u201coxygen generator\u201d to concentrate atmospheric oxygen and feeds pure, moist, oxygen through a fine, soft tube to a dressing-like \u201coxygen distribution system\u201d, which is placed over the wound and is held in place by a conventional dressing. The aim was to determine the effectiveness of Natrox\n                    <jats:sup>\u2122<\/jats:sup>\n                    for non-healing diabetic foot ulcers (DFU) over a 3-month period.Longitudinal, single-arm, open prospective registry study using 12 weeks of TOT using a 4 week run-in period. 20 patients recruited to OTONAL had chronic DFU greater than 3 months duration or minor amputation sites with less than 50% healing in 4 weeks.There were 13 (65%) males and the mean age was 65.7 (\u00b111.6) years. The mean glycated haemoglobin (HbA1c) was 6.9 (\u00b11.3) mmol mol\n                    <jats:sup>\u22121<\/jats:sup>\n                    and mean wound duration before TOT was 114 (\u00b179.1) days. 18\/20 (90.0%) patients had concomitant lower limb revascularization angioplasty for chronic limb threatening ischaemia. The mean size of the foot ulcer at baseline was 11.3\u2009\u00b1\u200914.8\u2005cm\n                    <jats:sup>2<\/jats:sup>\n                    and mean transcutaneous oxygen measurement value was 34.1 (\u00b119.6) mm\u2009Hg. Wound closure of &gt;75% was observed in 14\/20 (70.0%) patients. There was a 91.3% (\u00b114.9%) wound area reduction by 3 months (P\u2009=\u2009.001) and mean time for 100% closure was 77.6\u2009\u00b1\u200932.5 days. Mean pain scores reduced from 2.4 (\u00b11.8) at baseline to .5 (\u00b11.0) at 3 months (P\u2009=\u2009.008). All patients were very satisfied using the ambulatory device. Use of TOT in chronic diabetic foot wounds stimulates a healing state, underpinning the concept that oxygen plays a central role in wound healing. Our results are more compelling if you consider they started with relatively large-sized DFUs and majority of patients were frail with underlying peripheral artery disease. (NCT03863054)\n                  <\/jats:p>","DOI":"10.1177\/15347346211053694","type":"journal-article","created":{"date-parts":[[2021,11,6]],"date-time":"2021-11-06T11:33:43Z","timestamp":1636198423000},"page":"326-337","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":17,"title":["An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (Natrox\n                    <sup>\u2122<\/sup>\n                    ) on the Rates of Healing of Chronic DiAbetic Foot Ulcers (OTONAL Trial)"],"prefix":"10.1177","volume":"23","author":[{"given":"Tjun Yip","family":"Tang","sequence":"first","affiliation":[{"name":"Department of Vascular Surgery, Singapore General Hospital, Singapore"},{"name":"Duke NUS Graduate Medical School, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manfred Y. Q.","family":"Mak","sequence":"additional","affiliation":[{"name":"Department of Podiatry, Singapore General Hospital, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. J. Q.","family":"Yap","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, Singapore General Hospital, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. E. C.","family":"Boey","sequence":"additional","affiliation":[{"name":"Department of Podiatry, National University Hospital, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sze Ling","family":"Chan","sequence":"additional","affiliation":[{"name":"Health Services Research Center, SingHealth, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3057-5983","authenticated-orcid":false,"given":"Shereen X. Y.","family":"Soon","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, Singapore General Hospital, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I. A. B.","family":"Ishak","sequence":"additional","affiliation":[{"name":"Department of Podiatry, Singapore General Hospital, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. W. L.","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Podiatry, Singapore General Hospital, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xin Jie","family":"Soh","sequence":"additional","affiliation":[{"name":"Department of Podiatry, Singapore General Hospital, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wan Xi","family":"Goh","sequence":"additional","affiliation":[{"name":"Department of Podiatry, Singapore General Hospital, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2021,11,6]]},"reference":[{"key":"bibr1-15347346211053694","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)67698-2"},{"key":"bibr2-15347346211053694","doi-asserted-by":"publisher","DOI":"10.4239\/wjd.v7.i7.153"},{"key":"bibr3-15347346211053694","doi-asserted-by":"publisher","DOI":"10.1186\/s13047-020-00383-2"},{"key":"bibr4-15347346211053694","doi-asserted-by":"publisher","DOI":"10.1136\/bmjdrc-2013-000012"},{"key":"bibr5-15347346211053694","doi-asserted-by":"publisher","DOI":"10.1111\/1753-0407.12604"},{"key":"bibr6-15347346211053694","unstructured":"Organisation for Economic Co-operation and Development (OECD).\n                      Cardiovascular Disease and Diabetes: Policies for Better Health and Quality of Care. OECD Health Policy Studies\n                      . Paris: OECD Publishing; 2015. http:\/\/www.oecd.org\/health\/cardiovascular-disease-and-diabetes-policies-for-better-health-and-quality-of-care-9789264233010-en.htm. 2015."},{"key":"bibr7-15347346211053694","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.13333"},{"key":"bibr8-15347346211053694","doi-asserted-by":"publisher","DOI":"10.1089\/wound.2011.0319"},{"key":"bibr9-15347346211053694","doi-asserted-by":"publisher","DOI":"10.1111\/iwj.12324"},{"key":"bibr10-15347346211053694","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.12069"},{"key":"bibr11-15347346211053694","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-2160"},{"key":"bibr12-15347346211053694","doi-asserted-by":"publisher","DOI":"10.2337\/dc17-0654"},{"key":"bibr13-15347346211053694","doi-asserted-by":"publisher","DOI":"10.12968\/jowc.2018.27.7.426"},{"key":"bibr14-15347346211053694","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.12490"},{"key":"bibr15-15347346211053694","doi-asserted-by":"publisher","DOI":"10.12968\/jowc.2021.30.Sup5.S7"},{"key":"bibr16-15347346211053694","doi-asserted-by":"crossref","unstructured":"Thanigaimani S, Singh T, Golledge J. 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Vienna, Austria: R Foundation for Statistical Computing; 2018."},{"key":"bibr20-15347346211053694","doi-asserted-by":"publisher","DOI":"10.1111\/dme.13313"},{"key":"bibr21-15347346211053694","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-8587(18)30262-6"},{"key":"bibr22-15347346211053694","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-020-01415-8"},{"key":"bibr23-15347346211053694","author":"Beckman JA","journal-title":"Circulation"},{"key":"bibr24-15347346211053694","doi-asserted-by":"publisher","DOI":"10.2337\/dc10-1985"},{"key":"bibr25-15347346211053694","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.22.6.951"},{"key":"bibr26-15347346211053694","doi-asserted-by":"publisher","DOI":"10.1177\/1708538117753213"},{"key":"bibr27-15347346211053694","doi-asserted-by":"publisher","DOI":"10.12968\/jowc.2018.27.Sup9.S30"},{"key":"bibr28-15347346211053694","doi-asserted-by":"publisher","DOI":"10.2337\/dc19-0476"},{"issue":"1","key":"bibr29-15347346211053694","volume":"36","author":"Rayman G","year":"2020","journal-title":"Diabetes Metab Res Rev"},{"key":"bibr30-15347346211053694","doi-asserted-by":"publisher","DOI":"10.11622\/smedj.2020104"},{"key":"bibr31-15347346211053694","doi-asserted-by":"publisher","DOI":"10.1089\/wound.2017.0729"},{"key":"bibr32-15347346211053694","doi-asserted-by":"publisher","DOI":"10.1177\/1534734620910318"}],"container-title":["The International Journal of Lower Extremity Wounds"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/15347346211053694","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/15347346211053694","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/15347346211053694","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T10:04:58Z","timestamp":1777457098000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/15347346211053694"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,11,6]]},"references-count":32,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2024,6]]}},"alternative-id":["10.1177\/15347346211053694"],"URL":"https:\/\/doi.org\/10.1177\/15347346211053694","relation":{},"ISSN":["1534-7346","1552-6941"],"issn-type":[{"value":"1534-7346","type":"print"},{"value":"1552-6941","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,11,6]]}}}