{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T17:55:03Z","timestamp":1785779703199,"version":"3.56.0"},"reference-count":12,"publisher":"Public Library of Science (PLoS)","issue":"8","license":[{"start":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T00:00:00Z","timestamp":1785715200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"\n Background<\/jats:title>\n The probe-to-bone (PTB) is a simple, bedside clinical test that can assist in diagnosis of diabetic foot osteomyelitis (OM). The utility of PTB varies depending on the population, with a lower positive predictive value in lower-risk outpatients.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n This is a protocol for a pilot, feasibility and safety multi-centre randomized controlled trial. 80 patients, with PTB diabetic foot ulcers and without initial X-ray findings of OM, will be randomized to 2 weeks antibiotic therapy or 6 weeks of antibiotic therapy at a 1:1 ratio. The primary outcomes will be to assess feasibility (eligibility to recruitment ratio, retention rate, adherence to protocol and cross-over from intervention to control group) and safety (serious adverse events, antibiotic-associated adverse events,\n Clostridium difficile<\/jats:italic>\n associated diarrhea and hospitalization) in this cohort. Exploratory clinical outcomes will include recommencement\/continuation of antibiotic therapy or requirement for surgery, and the proportion of participants that demonstrate new radiological changes of OM on serial X-ray imaging. Follow-up will occur at 14 days, 42 days and 90 days post-recruitment.\n <\/jats:p>\n <\/jats:sec>\n \n Discussion<\/jats:title>\n This is the first randomised trial assessing the feasibility and safety of shorter antibiotic therapies in patients with low-risk PTB diabetic foot ulcers. The findings of this trial will inform the design of future large multi-site randomised trials to risk stratify diabetic foot ulcers and better understand how to treat diabetic foot OM.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n Australian New Zealand Clinical Trials Registry (ANZCTR): 12624000266561. Registered on 15\/03\/2024.Registration URL:\n https:\/\/www.anzctr.org.au\/Trial\/Registration\/TrialReview.aspx?id=386823&isReview=true<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1371\/journal.pone.0354611","type":"journal-article","created":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T17:24:06Z","timestamp":1785777846000},"page":"e0354611","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pilot randomised controlled trial of probe to bone diabetic foot ulcer therapy (PROBE-DFU trial) \u2013 Study protocol"],"prefix":"10.1371","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6739-0424","authenticated-orcid":true,"given":"Satwik","family":"Motaganahalli","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1597-9421","authenticated-orcid":true,"given":"Sara","family":"Vogrin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toby","family":"Richards","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Trisha","family":"Peel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason","family":"Trubiano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2026,8,3]]},"reference":[{"issue":"1","key":"pone.0354611.ref001","doi-asserted-by":"crossref","first-page":"8","DOI":"10.1186\/s13047-021-00447-x","article-title":"Diabetes-related foot disease in Australia: a systematic review of the prevalence and incidence of risk factors, disease and amputation in Australian populations","volume":"14","author":"Y Zhang","year":"2021","journal-title":"J Foot Ankle Res"},{"key":"pone.0354611.ref002","article-title":"Controversies in diagnosing and managing osteomyelitis of the foot in diabetes","author":"WJ Jeffcoate","year":"2004","journal-title":"Clin Infect Dis"},{"key":"pone.0354611.ref003","article-title":"Guidelines on the diagnosis and treatment of foot infection in persons with diabetes (IWGDF 2019 update)","author":"BA Lipsky","year":"2020","journal-title":"Diabetes Metab Res Rev"},{"issue":"9","key":"pone.0354611.ref004","doi-asserted-by":"crossref","first-page":"721","DOI":"10.1001\/jama.1995.03520330051036","article-title":"Probing to bone in infected pedal ulcers. A clinical sign of underlying osteomyelitis in diabetic patients","volume":"273","author":"ML Grayson","year":"1995","journal-title":"JAMA"},{"issue":"7","key":"pone.0354611.ref005","doi-asserted-by":"crossref","first-page":"944","DOI":"10.1093\/cid\/ciw445","article-title":"Diagnostic Accuracy of Probe to Bone to Detect Osteomyelitis in the Diabetic Foot: A Systematic Review","volume":"63","author":"K Lam","year":"2016","journal-title":"Clin Infect Dis"},{"issue":"2","key":"pone.0354611.ref006","doi-asserted-by":"crossref","first-page":"270","DOI":"10.2337\/dc06-1572","article-title":"Probe-to-bone test for diagnosing diabetic foot osteomyelitis: reliable or relic?","volume":"30","author":"LA Lavery","year":"2007","journal-title":"Diabetes Care"},{"issue":"1","key":"pone.0354611.ref007","doi-asserted-by":"crossref","DOI":"10.4084\/MJHID.2022.055","article-title":"The Role of Serial Radiographs in Diagnosing Diabetic Foot Bone Osteomyelitis","volume":"14","author":"A Leone","year":"2022","journal-title":"Mediterr J Hematol Infect Dis"},{"issue":"5","key":"pone.0354611.ref008","doi-asserted-by":"crossref","first-page":"369","DOI":"10.7547\/1020369","article-title":"Performance of the probe-to-bone test in a population suspected of having osteomyelitis of the foot in diabetes","volume":"102","author":"M Mutluoglu","year":"2012","journal-title":"J Am Podiatr Med Assoc"},{"issue":"4","key":"pone.0354611.ref009","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0267412","article-title":"The efficacy of inflammatory markers in diagnosing infected diabetic foot ulcers and diabetic foot osteomyelitis: Systematic review and meta-analysis","volume":"17","author":"H Sharma","year":"2022","journal-title":"PLoS One"},{"issue":"4","key":"pone.0354611.ref010","doi-asserted-by":"crossref","first-page":"396","DOI":"10.2174\/1573399811666150713104401","article-title":"The Role of Biomarkers to Diagnose Diabetic Foot Osteomyelitis. A Meta-analysis","volume":"12","author":"SA Victoria van Asten","year":"2016","journal-title":"Curr Diabetes Rev"},{"key":"pone.0354611.ref011","doi-asserted-by":"crossref","first-page":"264","DOI":"10.1186\/1745-6215-15-264","article-title":"Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study","volume":"15","author":"MD Teare","year":"2014","journal-title":"Trials"},{"key":"pone.0354611.ref012","doi-asserted-by":"crossref","first-page":"64","DOI":"10.1186\/s40814-016-0105-8","article-title":"CONSORT 2010 statement: extension to randomised pilot and feasibility trials","volume":"2","author":"SM Eldridge","year":"2016","journal-title":"Pilot Feasibility Stud"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0354611","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T17:24:08Z","timestamp":1785777848000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0354611"}},"subtitle":[],"editor":[{"given":"Felix","family":"Bongomin","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,8,3]]},"references-count":12,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2026,8,3]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0354611","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,3]]}}}