{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T16:39:44Z","timestamp":1773333584608,"version":"3.50.1"},"reference-count":19,"publisher":"BMJ","issue":"9","funder":[{"name":"Vascular and Radiology Research Fund","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]},{"name":"2020\n Australia and New Zealand Society for Vascular Surgery (ANZSVS)\n Vascular Foundation Project Grant","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"published-print":{"date-parts":[[2021,9]]},"abstract":"\n Introduction<\/jats:title>\n Diabetic foot disease is a common condition globally and is\n over-represented in indigenous populations. The propensity for patients\n with diabetic foot disease to undergo minor or major limb amputation is\n a concern. Diabetic foot disease and lower limb amputation are\n debilitating for patients and have a substantial financial impact on\n health services. The purpose of this multicentre study is to\n prospectively report the presentation, management and outcomes of\n diabetic foot disease, to validate existing scoring systems and assess\n long term outcomes for these patients particularly in relation to major\n limb amputation.<\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n This is a multisite, international, prospective observational study,\n being undertaken at Waikato Hospital, New Zealand (NZ); Sir Charles\n Gairdner Hospital, the Royal Adelaide Hospital and the Queen Elizabeth\n Hospital, Australia. Consecutive participants with diabetic foot disease\n that meet inclusion criteria and agree to participate will be recruited\n from multidisciplinary team diabetic foot clinic, vascular clinic,\n dialysis and admission to hospital. Follow-up of participants will occur\n at 1, 3, 6 and 12 months. At recruitment and follow-up reviews,\n information about service details, demographic and clinical history,\n wound data and discharge information will be recorded. The primary\n outcomes are the time to wound healing, major amputation, overall\n mortality and amputation-free survival at 12 months. This study started\n in NZ in August 2020 and will commence in Australian sites in early\n 2021.<\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n New Zealand Central Health and Disability Ethics Committee\n (20\/CEN\/122), Waikato DHB Research Department (RDO020044), Quality\n Improvement HoD Sir Charles Gairdner Hospital (39715) and the Central\n Adelaide Local Health Network (CALHN) Human Research Ethics Committee\n (13928). Results will be presented at international conferences and\n published in peer-reviewed journals.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n Australian New Zealand Clinical Trials Registry\n (ACTRN12621000337875).<\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-050833","type":"journal-article","created":{"date-parts":[[2022,2,14]],"date-time":"2022-02-14T09:45:22Z","timestamp":1644831922000},"page":"e050833","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["Protocol for a prospective observational study: the Australia and New\n Zealand Diabetic and Ischaemic Foot Outcomes Study (ANZ-DIFOS)"],"prefix":"10.1136","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6330-2810","authenticated-orcid":false,"given":"Odette","family":"Hart","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7781-4748","authenticated-orcid":false,"given":"Shirley","family":"Jansen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6258-5997","authenticated-orcid":false,"given":"Robert","family":"Fitridge","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4921-8433","authenticated-orcid":false,"given":"Manar","family":"Khashram","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2021,9,2]]},"reference":[{"key":"2022021401264939000_11.9.e050833.1","doi-asserted-by":"crossref","unstructured":"van Netten JJ , Bus SA , Apelqvist J , International\n Working Group on the Diabetic Foot guidelines . Definitions and criteria\n for diabetic foot disease. Diabetes Metab Res Rev\n 2019;36.doi:10.1002\/dmrr.3268","DOI":"10.1002\/dmrr.3268"},{"key":"2022021401264939000_11.9.e050833.2","doi-asserted-by":"crossref","first-page":"1725","DOI":"10.1016\/S0140-6736(05)67699-4","article-title":"Treatment for diabetic foot ulcers","volume":"366","author":"Cavanagh","year":"2005","journal-title":"The Lancet"},{"key":"2022021401264939000_11.9.e050833.3","doi-asserted-by":"crossref","first-page":"2367","DOI":"10.1056\/NEJMra1615439","article-title":"Diabetic foot ulcers and their recurrence","volume":"376","author":"Armstrong","year":"2017","journal-title":"N Engl J Med Overseas Ed"},{"key":"2022021401264939000_11.9.e050833.4","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-017-4488-8"},{"key":"2022021401264939000_11.9.e050833.5","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)67698-2"},{"key":"2022021401264939000_11.9.e050833.6","doi-asserted-by":"crossref","first-page":"288","DOI":"10.5694\/mja17.01198","article-title":"Pathway to ending avoidable diabetes-related amputations in Australia","volume":"209","author":"Lazzarini","year":"2018","journal-title":"Med J Aust"},{"key":"2022021401264939000_11.9.e050833.7","doi-asserted-by":"crossref","first-page":"648","DOI":"10.1016\/j.jvs.2016.03.421","article-title":"The financial burden of surgical and endovascular treatment of diabetic foot wounds","volume":"64","author":"Joret","year":"2016","journal-title":"J Vasc Surg"},{"key":"2022021401264939000_11.9.e050833.8","doi-asserted-by":"crossref","DOI":"10.1186\/s13047-017-0230-5","article-title":"Defining the gap: a systematic review of the difference in rates of diabetes-related foot complications in Aboriginal and Torres Strait Islander Australians and non-Indigenous Australians","volume":"10","author":"West","year":"2017","journal-title":"J Foot Ankle Res"},{"key":"2022021401264939000_11.9.e050833.9","doi-asserted-by":"crossref","first-page":"55","DOI":"10.1111\/dme.12807","article-title":"Ethnicity and risk of lower limb amputation in people with type 2 diabetes: a prospective cohort study","volume":"33","author":"Robinson","year":"2016","journal-title":"Diabet Med"},{"key":"2022021401264939000_11.9.e050833.10","unstructured":"Monteiro-Soares M , Russell D , Boyko EJ .\n International Working group on the diabetic foot guideline: on the\n classification of diabetic foot ulcers, 2019."},{"key":"2022021401264939000_11.9.e050833.11","doi-asserted-by":"crossref","first-page":"220","DOI":"10.1016\/j.jvs.2013.08.003","article-title":"The Society for vascular surgery lower extremity threatened limb classification system: risk stratification based on wound, ischemia, and foot infection (WIfI)","volume":"59","author":"Mills","year":"2014","journal-title":"J Vasc Surg"},{"key":"2022021401264939000_11.9.e050833.12","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.1016\/j.ejvs.2019.05.006","article-title":"Global vascular guidelines on the management of chronic limb-threatening ischemia","volume":"58","author":"Conte","year":"2019","journal-title":"Eur J Vasc Endovasc Surg"},{"key":"2022021401264939000_11.9.e050833.13","doi-asserted-by":"crossref","first-page":"232","DOI":"10.1002\/dmrr.2756","article-title":"Assessment of foot perfusion in patients with a diabetic foot ulcer","volume":"32 Suppl 1","author":"Forsythe","year":"2016","journal-title":"Diabetes Metab Res Rev"},{"key":"2022021401264939000_11.9.e050833.14","doi-asserted-by":"crossref","first-page":"308","DOI":"10.1016\/j.avsg.2019.03.002","article-title":"Plantar acceleration time: a novel technique to evaluate arterial flow to the foot","volume":"60","author":"Sommerset","year":"2019","journal-title":"Ann Vasc Surg"},{"key":"2022021401264939000_11.9.e050833.15","unstructured":"Health Research Council of New Zealand . The New\n Zealand health research prioritisation framework. Wellington: Ministry\n of Business, Innovation and Employment and the Ministry of Health,\n 2019."},{"key":"2022021401264939000_11.9.e050833.16","article-title":"Guidelines on diagnosis, prognosis, and management of peripheral artery disease in patients with foot ulcers and diabetes (IWGDF 2019 update)","volume":"36 Suppl 1","author":"Hinchliffe","year":"2020","journal-title":"Diabetes Metab Res Rev"},{"key":"2022021401264939000_11.9.e050833.17","unstructured":"Ministry of Health . Cardiovascular disease risk\n assessment and management for primary care. Wellington: Ministry of\n Health, 2018."},{"key":"2022021401264939000_11.9.e050833.18","unstructured":"Schaper NC , van Netten JJ , Apelqvist J . IWGDF\n practical guidelines on the prevention and management of diabetic foot\n disease, 2019."},{"key":"2022021401264939000_11.9.e050833.19","doi-asserted-by":"crossref","first-page":"e308","DOI":"10.1016\/S2589-7500(19)30128-1","article-title":"Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study","volume":"1","author":"Abbott","year":"2019","journal-title":"Lancet Digit Health"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2021-050833","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,20]],"date-time":"2023-08-20T01:21:17Z","timestamp":1692494477000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2021-050833"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,9]]},"references-count":19,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2021,9,2]]},"published-print":{"date-parts":[[2021,9]]}},"alternative-id":["10.1136\/bmjopen-2021-050833"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2021-050833","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,9]]}}}