CODIFI2: Randomised controlled trial to compare clinical and cost‐effectiveness of swabs versus tissue sampling to inform management of infected diabetic foot ulcers
Authors' conclusion
This 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.
Study context
- Population
- People with infected diabetic foot ulcers (DFU), 21 UK sitestarget 730
- Participants
- 149 people
- Comparison
- Wound swab vs tissue sampling
- Swabn = 75
- Tissuen = 74
- Primary endpoint
- Time to ulcer healing
Methodological detailsmulticentre, phase III, prospective, non-blind, 2-arm parallel group, minimisation, blinded outcome assessor, Follow-up 52-104 weeks, Target 730 participants for 90% power to detect a 12.5% difference in healing at 52 weeks; underpowered
- Multicentre
- Phase III
- Prospective
- Non-blind
- 2-arm parallel group
- Minimisation
- Blinded outcome assessor
- Follow-up 52-104 weeks
- Target 730 participants for 90% power to detect a 12.5% difference in healing at 52 weeks; underpowered
Primary result
As reported in the abstract
Confirmed healing as first event (cumulative incidence) · 52 weeks
Hazard ratio
1.01
95% CI 0.65–1.55
By group
Tissuevs Swab
HR 1.01 (95% CI 0.65–1.55)
Further findings
Days in hospital
Events
| Outcome | Swab | Tissue |
|---|---|---|
| Death during follow-up | 17 | 7 |
Safety
Amputation
Original publication
CODIFI2: Randomised controlled trial to compare clinical and cost‐effectiveness of swabs versus tissue sampling to inform management of infected diabetic foot ulcers. Diabet Med. Published 6 March 2025. doi:10.
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