Daily Chlorhexidine Wipes Do Not Significantly Reduce Diabetic Foot Complications, JAMA
A news study published in JAMA has determined that daily application of 2% chlorhexidine wipes for foot hygiene in diabetic veterans did not significantly decrease the risk of new foot complications compared with standard soap-and-water wipes. Diabetic foot ulcers are a severe and prevalent complication, and about 20% of them result in infections that necessitate lower extremity amputations. This study was conducted by Alison D. and fellow researchers.
This phase 2b double-blind placebo-controlled randomized clinical trial occurred from January 2019 to January 2023 at the Baltimore Veterans Affairs (VA) Medical Center. Patients had to be diabetic veterans with a risk for diabetic foot complications but without an acute foot infection. They were ambulatory and had intact feet. A total of 175 participants (97% male, mean age 68 years) were randomly assigned in a 1:1 ratio to receive either 2% chlorhexidine wipes (n = 88) or soap-and-water wipes (n = 87). The intervention lasted for one year, during which participants were instructed to use the assigned wipes daily, followed by the application of a standardized foot lotion.
Participants were supplied with lookalike wipes for blinding. The main outcome was time to first new foot complication, occurring after randomization and defined as chronic foot ulcer, foot infection, or amputation of a lower extremity. Data analysis was performed in an intention-to-treat fashion. Follow-up occurred over one year's median duration, during which adverse effects and intervention compliance were closely observed.
Key Findings
• In a year, 12 (14%) and 14 (16%) participants in the chlorhexidine and soap-and-water groups, respectively, developed new foot complications.
• The time to the first new foot complication was 232 days (IQR: 115-315 days) in both groups.
• No significant hazard reduction of new foot complications in the chlorhexidine group was seen compared with the soap-and-water group (hazard ratio, 0.83; 95% CI, 0.39-1.80).
• 60 adverse events were documented throughout the study, but none of them resulted from the intervention. The adherence was very high with 145 participants (83%) sustaining the intervention during the entire study period.
The study authors concluded that daily use of 2% chlorhexidine wipes did not significantly influence prevention of new diabetic foot complications among diabetic veterans in comparison with soap-and-water wipes. These findings are valuable for future research regarding how to optimize preventive interventions for diabetic foot complications.
Reference:
Lydecker AD, Kim JJ, Robinson GL, et al. Chlorhexidine vs Routine Foot Washing to Prevent Diabetic Foot Ulcers: A Randomized Clinical Trial. JAMA Netw Open. 2025;8(2):e2460087. doi:10.1001/jamanetworkopen.2024.60087
