Chlorhexidine vs Routine Foot Washing to Prevent Diabetic Foot Ulcers: A Randomized Clinical Trial
An erratum to this article was published (JAMA Netw Open, 3 Mar 2025 ↗)
Primary result · New foot complicationResult — go to the resultHazard ratio 0.83 95% CI 0.39–1.80Authors' conclusion
This randomized clinical trial found that daily use of chlorhexidine wipes for foot washing for 1 year did not lead to a significant reduction in the risk of new foot complications compared with daily use of soap-and-water wipes. The intervention was well tolerated, and the trial provides important lessons for future studies on diabetic foot ulcer prevention.
Study context
- Population
- Veterans with diabetes at high risk for diabetic foot complications, ambulatory, both feet, no current foot infection; Baltimore Veterans Affairs (VA) Medical Center, 2019–2023randomized 1:1
- Participants
- 175 veterans
- Comparison
- Daily 2% chlorhexidine wipes vs soap-and-water wipes on the feet for 1 year
- Chlorhexidinen = 88
- Controln = 87reference
- Primary endpoint
- Time in days from randomization to new foot complication (chronic foot ulcer, foot infection or foot amputation)
Methodological detailsdouble-blind, placebo-controlled, phase 2b, single-centre
- Double-blind
- Placebo-controlled
- Phase 2b
- Single-centre
Primary result
New foot complication · within 1 year
Hazard ratio
0.83
95% CI 0.39–1.80
Events by treatment group
Chlorhexidinevs Control
HR 0.83 (95% CI 0.39–1.80)
As reported in the abstract
Safety
Adverse events and tolerability
- Adverse events
- 60
- Adverse events related to study products or procedures
- 0
- Continued the intervention over the study period
- 145 (83%)
Original publication
Chlorhexidine vs Routine Foot Washing to Prevent Diabetic Foot Ulcers: A Randomized Clinical Trial. JAMA Netw Open. Published 3 February 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →