Trial reportDiabetic medicine : a journal of the British Diabetic Association2025
Concordance of molecular microbiology and conventional culture techniques for infected diabetic foot ulcer management.
Trial report in Diabetic medicine : a journal of the British Diabetic Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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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.
The trial behind it
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Swabs versus tissue samples for infected diabetic foot ulcers: the CODIFI2 RCT.Health technology assessment (Winchester, England) · 2025Trial
- Concordance of molecular microbiology and conventional culture techniques for infected diabetic foot ulcer management.Diabetic medicine : a journal of the British Diabetic Association · 2025Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
Abstract
aimThe management of infected diabetic foot ulcers (DFUs) requires balancing the need for timely interventions against the desire for targeted antibiotic therapy, which relies on laboratory results. This study aimed to evaluate concordance between molecular and conventional culture and sensitivity (C&S) methods in identifying bacteria from infected DFUs.
methodsThis study was conducted alongside CODIFI2, a Phase III randomised controlled trial comparing tissue sampling with wound swabbing. It assessed C&S and metagenomic 16S rRNA gene sequencing (M16S) in DFUs with suspected mild or moderate infections using both tissue and swab samples.
resultsIn 145 participants, C&S identified 248 microorganisms across 25 genera including eight anaerobic genera. M16S identified a greater number and diversity of microorganisms, detecting 455 across 40 genera, including 173 anaerobes from 15 distinct genera. No bacterial growth was reported in 25.5% (95% CI: 18.0%-32.3%) of C&S samples, whereas M16S identified at least one organism in all samples. While the observed agreement between methods was high (75%), Cohen's Kappa revealed low concordance overall, except for Pseudomonas spp. and Streptococcus spp. (Kappa ≥ 0.5).
conclusionsM16S detected a broader microbial spectrum, including fastidious anaerobes, but its low concordance with C&S and lack of antibiotic sensitivity data, challenge its suitability as a replacement for C&S in mild or moderate DFU infections. It may offer advantages in infections where increased sensitivity is beneficial, particularly where extended culture approaches are recommended to detect fastidious or low-abundance organisms. For mild to moderate DFU infections, our findings support continued reliance on conventional C&S testing.
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Registered trials
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