Trial reportDiabetic medicine : a journal of the British Diabetic Association2025
CODIFI2: Randomised controlled trial to compare clinical and cost-effectiveness of swabs versus tissue sampling to inform management of infected diabetic foot ulcers.
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 3 papers, 1 of them a synthesis that pooled it.
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
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Development of a core descriptor set for studies assessing interventions for diabetes-related foot ulceration.Diabetologia · 2026Pooled it
- Swabs versus tissue samples for infected diabetic foot ulcers: the CODIFI2 RCT.Health technology assessment (Winchester, England) · 2025Trial
- CODIFI2: Randomised controlled trial to compare clinical and cost-effectiveness of swabs versus tissue sampling to inform management of infected diabetic foot ulcers.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
baims/hypothesisCODIFI2 compared wound swabbing and tissue sampling in people with infected diabetic foot ulcers (DFU) to determine the effects on clinical outcomes.
methodsMulticentre, Phase III, prospective, non-blind, 2-arm parallel group, randomised controlled trial comparing time to ulcer healing (primary outcome), proportions healed, antimicrobial regimen, ulcer area reduction, hospitalisation duration, and time to death for swab compared to tissue sampling. Allocation was via a central and independent randomisation system, with minimisation by DFU site, number, type, size, location, and duration. Follow-up was 52-104 weeks, with healing confirmed by a blinded assessor. Samplesize target was 730 participants for 90% power to detect a 12.5% difference in healing at 52 weeks.
resultsBetween May 2019 and May 2022, 149 participants were recruited (75 Swab, 74 Tissue) from 21 UK sites. The 52-week cumulative incidence of confirmed healing as the first event was 45.3% (33.5%-56.4%) and 44.6% (33.0-55.6%) for swab vs. tissue. The hazard ratio (HR) for healing for tissue vs. swab was 1.01 (95% CI 0.65-1.55). The median (IQR) days in hospital was 17 (12-39) for swab and 16 (10-32) for tissue. Seventeen swab and 7 tissue participants died during follow-up, and 18.7% and 24.3% of participants in the swab and tissue groups, respectively, had an amputation. CONCLUSIONS/
interpretationThis trial was underpowered to determine whether swab or tissue sampling impacted the rate of healing or time to healing. Clinical prescribing and patient outcomes differed slightly between groups; hence, the clinical benefit of tissue sampling is not established.
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