ArticlePloS one2026
Pilot randomised controlled trial of probe to bone diabetic foot ulcer therapy (PROBE-DFU trial) - Study protocol.
Article in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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.
methodsThis 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, Clostridium difficile 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. DISCUSSION: 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.
trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR): 12624000266561. Registered on 15/03/2024.Registration URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=386823&isReview=true.
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