Trial reportDiabetic medicine : a journal of the British Diabetic Association2025
Cost-effectiveness of swab versus tissue sampling for infected diabetic foot ulcers from the CODIFI2 randomised controlled trial.
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 4 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
4 citing papers in PubMed.
- Swabs versus tissue samples for infected diabetic foot ulcers: the CODIFI2 RCT.Health technology assessment (Winchester, England) · 2025Trial
- Cost-effectiveness of swab versus tissue sampling for infected diabetic foot ulcers from the CODIFI2 randomised controlled trial.Diabetic medicine : a journal of the British Diabetic Association · 2025Trial
- Trial
- Recommendations for microbiological sampling in infected hard-to-heal wounds: an Italian association for cutaneous ulcers (AIUC) perspective.Frontiers in surgery · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
Abstract
aimsTo compare the cost-effectiveness of wound swabbing versus tissue sampling for infected diabetic foot ulcers.
methodsThis multi-centre, Phase III, prospective, unblinded, two-arm parallel group, randomised controlled trial compared clinical (reported elsewhere) and economic outcomes of swab versus tissue sampling over a 52-104 week period. Resource use was logged using case record forms and patient questionnaire at weeks 4, 12, 26, 39, 52 and 104, costed using laboratory and published sources from the UK NHS perspective, at 2021/2022 price-year. EQ-5D-3L questionnaires issued at these time points were used to derive quality-adjusted life-years (QALYs). To account for imbalances such as age, a regression-based approach was used to estimate survival, expected costs and QALYs between the sampling arms. Available case analysis (ACA) and multiple imputation methods were applied for self reported missing data, and ACA for researcher-collected data (survival, hospitalisations and antibiotic use). Probabilistic sensitivity analysis was used to assess the uncertainty of economic results.
resultsWe recruited 149 participants (75 swab, 74 tissue) from 21 UK sites, between 07 May 2019 and 28 April 2022 (last follow-up 28 April 2023). Planned sample size was 730 participants, for 90% power to detect 12.5% difference in healing at 52 weeks, but the trial stopped early due to low recruitment. Expected QALYs in the swab-sampling arm were greater than in the tissue-sampling arm at weeks 26, 52 and 104. The cost of tissue sampling was greater than of swabbing when including antibiotics and hospitalisation. Swab sampling participants had higher QALYs and lower costs across weeks 26-52, reducing slightly by week 104.
conclusionsBecause of higher costs, lower QALYs and lack of evidence of benefit, potentially due to the trial being underpowered, tissue sampling was dominated by wound swabbing in the cost-effectiveness analysis.
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Registered trials
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