Abstract
BackgroundDiabetic foot osteomyelitis (DFO) poses a major disease burden. It can generally be treated with long-term antibacterial therapy. International guidelines recommend to base antibacterial therapy choices on percutaneous bone biopsy culture, while in practice, therapy is frequently based on (less invasive) ulcer bed cultures. It is currently unknown if treatment outcomes of DFO differ depending on the chosen diagnostic strategy.MethodsThe BeBoP trial is a multicentre; randomised controlled; physician-, researcher- and subject-blinded; clinical trial comparing two diagnostic strategies in persons with DFO. Culture-directed antibacterial therapy will be based on either percutaneous bone biopsy culture results (intervention group) or ulcer bed biopsy culture results (comparison group). We will enrol 80 subjects with diabetes mellitus (≥ 18 years) and DFO, and we will use block randomisation stratified per centre to randomise them in a 1:1 allocation. The primary outcome is remission of DFO 12 months after enrolment. The secondary outcomes are the time to remission, signs of inflammation or ulceration at the primary location of infection at 6 and 12 months, microbiological and molecular profiles of culture outcomes, surgical interventions including amputation, total antibacterial therapy duration, infection-free survival days, adverse events, quality of life and survival. We will compare the outcomes by intention-to-treat and per-protocol analysis.DiscussionWe aim to compare clinical remission in persons with DFO treated with antibacterial therapy based on either percutaneous bone biopsy culture results or ulcer bed biopsy culture results.Trial registrationNetherlands Trial Register NL 7582. Registered on 05 March 2019
Highlights
Diabetic foot osteomyelitis (DFO) poses a major disease burden
In a prospective cohort study, in 13% of subjects, antibacterial therapy did not cover all causative bacteria, and 18.5% of subjects were treated with antibacterial therapy with an overly broad spectrum of activity when treatment was based on a biopsy through the ulcer bed instead of a percutaneous bone biopsy [10]
A retrospective cohort study showed that subjects treated with antibacterial therapy targeted at bacteria of bone biopsy cultures heal in 80%, compared with 50% of subjects treated with antibacterial therapy targeted at bacteria of superficial ulcer swab cultures [11]
Summary
Diabetic foot osteomyelitis (DFO) poses a major disease burden. It can generally be treated with long-term antibacterial therapy. International guidelines recommend to base antibacterial therapy choices on percutaneous bone biopsy culture, while in practice, therapy is frequently based on (less invasive) ulcer bed cultures. It is currently unknown if treatment outcomes of DFO differ depending on the chosen diagnostic strategy. In a prospective cohort study, in 13% of subjects, antibacterial therapy did not cover all causative bacteria, and 18.5% of subjects were treated with antibacterial therapy with an overly broad spectrum of activity when treatment was based on a biopsy through the ulcer bed instead of a percutaneous bone biopsy [10]. No prospective trial data are available to compare the true difference in clinical outcomes between the two diagnostic strategies
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