{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T06:36:36Z","timestamp":1783578996471,"version":"3.55.0"},"reference-count":33,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2020,1,20]],"date-time":"2020-01-20T00:00:00Z","timestamp":1579478400000},"content-version":"unspecified","delay-in-days":19,"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":["14\/605"],"award-info":[{"award-number":["14\/605"]}],"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":[[2019,12,12]]},"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>One in four diabetes patients will develop a foot ulcer over their lifetime. The role of glycaemic control in the healing of foot ulcers in diabetes patients is not supported by randomised controlled trial (RCT) data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To determine the feasibility of an RCT of glycaemic control with intensive insulin therapy in diabetic foot ulcer, by assessing: entry criteria, fasting capillary blood glucose (FCBG) medication satisfaction and sensitivity of different ulcer-healing endpoints to glycaemic control.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Two substudies: one cross-sectional and one single-arm prospective.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Single-centre secondary care diabetic foot clinic in New Zealand.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Substudy 1: 78 participants consisting of all people \u226518 years with a diabetic foot ulcer presenting to the clinic over 35 weeks in 2015.<\/jats:p>\n                    <jats:p>Substudy 2: 15 participants from Substudy 1 consenting to intensive insulin therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>Substudy 1: None.<\/jats:p>\n                    <jats:p>Substudy 2: Intensive insulin therapy with standard podiatry care over 24 weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcome<\/jats:title>\n                    <jats:p>Substudy 1: Proportion of participants satisfying potential RCT entry criteria; medication satisfaction (Diabetes Medication Satisfaction).<\/jats:p>\n                    <jats:p>Substudy 2: FCBG, index ulcer healing time, index ulcer size, health-related quality of life (HRQoL; EuroQol 5 Dimensions 5 Levels and Diabetic Foot Ulcer Scale-Short Form).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Proportion in Substudy 1 satisfying all entry criteria was 31% (95% CI 21 to 42). FCBG values decreased between baseline and study end (difference \u22123.7 mmol\/L, 95% CI \u22126.5 to \u22120.8); 83% (95% CI 44 to 95) of ulcers healed by 24 weeks. FCBG correlated negatively with medication satisfaction. Ulcer area logarithm was most sensitive to FCBG changes, displaying significant negative correlation with HRQoL outcomes. Detecting a 30% between-group difference in this outcome (80% power, \u03b1=5%) requires 220 participants per arm, achievable within 1 year with 15 centres similar to study setting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>An adequately powered RCT requires cooperation between a large number of centres. Ulcer area logarithm should be primary endpoint.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ANZCTR ACTRN12617001414303<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2019-029009","type":"journal-article","created":{"date-parts":[[2020,1,21]],"date-time":"2020-01-21T04:34:22Z","timestamp":1579581262000},"page":"e029009","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":19,"title":["Does intensive glycaemic control promote healing in diabetic foot ulcers? \u2013 a feasibility study"],"prefix":"10.1136","volume":"10","author":[{"given":"Ajith","family":"Dissanayake","sequence":"first","affiliation":[{"name":"Endocrinology and Diabetes, Counties Manukau District Health Board, Auckland, New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3153-2953","authenticated-orcid":false,"given":"Alain C","family":"Vandal","sequence":"additional","affiliation":[{"name":"Department of Statistics, University of Auckland, Auckland, New Zealand"},{"name":"Ko Awatea, Counties Manukau Health, Auckland, New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Veronica","family":"Boyle","sequence":"additional","affiliation":[{"name":"Endocrinology and Diabetes, Counties Manukau District Health Board, Auckland, New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane","family":"Park","sequence":"additional","affiliation":[{"name":"Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bobbie","family":"Milne","sequence":"additional","affiliation":[{"name":"Middlemore Clinical Trials, Auckland, New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger","family":"Grech","sequence":"additional","affiliation":[{"name":"Podiatry, Counties Manukau Health, Auckland, New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony","family":"Ng","sequence":"additional","affiliation":[{"name":"Podiatry, Counties Manukau Health, Auckland, New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2020,1,20]]},"reference":[{"key":"2025121604462444000_10.1.e029009.1","doi-asserted-by":"crossref","first-page":"3S","DOI":"10.1016\/j.jvs.2015.10.003","article-title":"The management of diabetic foot: a clinical practice guideline by the Society for vascular surgery in collaboration with the American podiatric Medical association and the Society for vascular medicine","volume":"63","author":"Hingorani","year":"2016","journal-title":"J Vasc Surg"},{"key":"2025121604462444000_10.1.e029009.2","unstructured":"Australian Institute of health and welfare, 2008. Available: http:\/\/wwwaihwgovau\/WorkArea\/DownloadAssetaspx?id=6442453674"},{"key":"2025121604462444000_10.1.e029009.3","doi-asserted-by":"publisher","DOI":"10.1086\/383275"},{"key":"2025121604462444000_10.1.e029009.4","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.27.9.2129"},{"key":"2025121604462444000_10.1.e029009.5","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-5491.2004.01275.x"},{"key":"2025121604462444000_10.1.e029009.6","doi-asserted-by":"publisher","DOI":"10.2337\/diaclin.27.2.52"},{"key":"2025121604462444000_10.1.e029009.7","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1002\/dmrr.2266","article-title":"Lessons from Eurodiale","volume":"28","author":"Schaper","year":"2012","journal-title":"Diabetes Metab Res Rev"},{"key":"2025121604462444000_10.1.e029009.8","doi-asserted-by":"crossref","first-page":"114","DOI":"10.1016\/j.foot.2010.09.002","article-title":"An assessment of peripheral vascular disease in patients with diabetic foot ulcer","volume":"20","author":"Ikem","year":"2010","journal-title":"Foot"},{"key":"2025121604462444000_10.1.e029009.9","doi-asserted-by":"publisher","DOI":"10.1177\/1534734608318236"},{"key":"2025121604462444000_10.1.e029009.10","doi-asserted-by":"crossref","first-page":"8","DOI":"10.1002\/dmrr.2239","article-title":"Advances in the epidemiology, pathogenesis and management of diabetic peripheral neuropathy","volume":"28","author":"Tesfaye","year":"2012","journal-title":"Diabetes Metab Res Rev"},{"key":"2025121604462444000_10.1.e029009.11","doi-asserted-by":"crossref","unstructured":"Fernando ME , Seneviratne RM , Tan YM , et al . Intensive versus conventional glycaemic control for treating diabetic foot ulcers. Cochrane Database Syst Rev 2016;22.doi:10.1002\/14651858.CD010764.pub2","DOI":"10.1002\/14651858.CD010764.pub2"},{"key":"2025121604462444000_10.1.e029009.12","doi-asserted-by":"crossref","first-page":"22S","DOI":"10.1016\/j.jvs.2015.10.005","article-title":"A systematic review and meta-analysis of glycemic control for the prevention of diabetic foot syndrome","volume":"63","author":"Hasan","year":"2016","journal-title":"J Vasc Surg"},{"key":"2025121604462444000_10.1.e029009.13","doi-asserted-by":"publisher","DOI":"10.1097\/01.prs.0000225459.93750.29"},{"key":"2025121604462444000_10.1.e029009.14","doi-asserted-by":"publisher","DOI":"10.1038\/jid.2011.176"},{"key":"2025121604462444000_10.1.e029009.15","first-page":"1103","article-title":"Hyperglycaemic conditions decrease cultured keratinocyte mobility: implications for impaired wound healing in patients with diabetes","volume":"159","author":"Lan","year":"2008","journal-title":"Br J Dermatol"},{"key":"2025121604462444000_10.1.e029009.16","first-page":"26","article-title":"Risk factors associated with healing chronic diabetic foot ulcers: the importance of hyperglycemia","volume":"52","author":"Marston","year":"2006","journal-title":"Ostomy Wound Manage"},{"key":"2025121604462444000_10.1.e029009.17","doi-asserted-by":"crossref","first-page":"1962","DOI":"10.1038\/jid.2011.269","article-title":"Diabetic control affects healing rates in neuropathic and vasculopathic patients","volume":"131","author":"Miner","year":"2011","journal-title":"J Invest Dermatol"},{"key":"2025121604462444000_10.1.e029009.18","doi-asserted-by":"crossref","first-page":"1703","DOI":"10.1007\/s00125-014-3248-2","article-title":"Intensified insulin treatment is associated with improvement in skin microcirculation and ischaemic foot ulcer in patients with type 1 diabetes mellitus: a long-term follow-up study","volume":"57","author":"Rathsman","year":"2014","journal-title":"Diabetologia"},{"key":"2025121604462444000_10.1.e029009.19","doi-asserted-by":"crossref","first-page":"1060","DOI":"10.1111\/j.1464-5491.2005.01606.x","article-title":"Does close glycaemic control promote healing in diabetic foot ulcers? report of a feasibility study","volume":"22","author":"Idris","year":"2005","journal-title":"Diabet Med"},{"key":"2025121604462444000_10.1.e029009.20","doi-asserted-by":"crossref","first-page":"309","DOI":"10.3111\/13696990903337017","article-title":"Examining and interpreting responsiveness of the diabetes medication satisfaction measure","volume":"12","author":"Brod","year":"2009","journal-title":"J Med Econ"},{"key":"2025121604462444000_10.1.e029009.21","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-005-1624-6"},{"key":"2025121604462444000_10.1.e029009.22","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.26.3.881"},{"key":"2025121604462444000_10.1.e029009.23","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-011-9903-x"},{"key":"2025121604462444000_10.1.e029009.24","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-012-0322-4"},{"key":"2025121604462444000_10.1.e029009.25","doi-asserted-by":"publisher","DOI":"10.2165\/00019053-200321170-00004"},{"key":"2025121604462444000_10.1.e029009.26","unstructured":"International Diabetes Federation . Global guideline for type 2 diabetes, 2012."},{"key":"2025121604462444000_10.1.e029009.27","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.26.6.1696"},{"key":"2025121604462444000_10.1.e029009.28","doi-asserted-by":"publisher","DOI":"10.1016\/j.cct.2011.12.002"},{"key":"2025121604462444000_10.1.e029009.29","doi-asserted-by":"publisher","DOI":"10.2337\/dc14-2585"},{"key":"2025121604462444000_10.1.e029009.30","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.22.5.692"},{"key":"2025121604462444000_10.1.e029009.31","doi-asserted-by":"crossref","first-page":"288","DOI":"10.1111\/wrr.12514","article-title":"Effect of systemic insulin treatment on diabetic wound healing","volume":"25","author":"Vatankhah","year":"2017","journal-title":"Wound Rep and Reg"},{"key":"2025121604462444000_10.1.e029009.32","doi-asserted-by":"publisher","DOI":"10.4103\/1947-2714.98590"},{"key":"2025121604462444000_10.1.e029009.33","first-page":"735","article-title":"Patients' satisfaction with diabetes medications in one Hospital, Saudi Arabia","volume":"6","author":"Al-Aujan","year":"2012","journal-title":"Patient Prefer Adherence"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2019-029009","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T12:48:12Z","timestamp":1765889292000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2019-029009"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,1]]},"references-count":33,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2020,1,20]]},"published-print":{"date-parts":[[2020,1]]}},"alternative-id":["10.1136\/bmjopen-2019-029009"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2019-029009","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,1]]}}}