medwireNews: Daily foot care using chlorhexidine wipes does not significantly reduce the risk for development of chronic foot ulcer, foot infection, or foot amputation relative to a care regime using soap-and-water wipes in people with diabetes, study findings indicate.
“Better interventions are needed to prevent the recurrence of foot ulcers in people with diabetes,” write Mary-Claire Roghmann (University of Maryland School of Medicine, Baltimore, USA) and co-authors in JAMA Network Open.
They explain that the commonly used broad-spectrum, topical antiseptic agent chlorhexidine can reduce the bacterial and fungal load of skin pathogens such as Staphylococcus aureus.
In the current study, Roghmann and team investigated its impact on the development of foot complications in 175 veterans with diabetes (97% men, mean age 68 years, 67% Black or African American) who were at high risk for diabetic foot complications. Risk factors included a history of diabetic foot ulcer; history of major foot surgery; history of moderate-to-severe foot infection; peripheral neuropathy, onychomycosis, and a glycated hemoglobin level above 8.0% (64 mmol/mol); peripheral neuropathy and peripheral artery disease (PAD); dialysis; Charcot foot; or PAD requiring surgery or stenting.
The researchers found that 12 (14%) of the 88 participants randomly assigned to use 2% chlorhexidine gluconate wipes on their feet daily for 1 year developed a new foot complication while taking part in the study. These included eight (67%) participants with new chronic foot ulcer, three (25%) with a moderate-to-severe foot infection from a new acute foot ulcer, and one (8%) who required foot amputation for a new acute foot ulcer.
By comparison, the foot complication rate was 16% among the 87 participants assigned to use soap-and-water wipes for 1 year. In this group, 13 (93%) of the 14 people with complications had new chronic foot ulcers, with the remaining patient (7%) needing foot amputation for a new acute foot ulcer.
The difference between the two groups was not statistically significant, and there was also no intra-group difference in the median time from randomization to development of the new foot complication, which was 232 days overall, with a range of 5 to 348 days.
The investigators report that “[a]dherence to wipe use was relatively high across both arms, with 77% of all participants reporting using at least 80% of the wipes.”
They say that this represents an increase in foot hygiene compared with baseline when 52% of all participants reported using a washcloth to clean their feet daily. However, routine swabs detected chlorhexidine on the feet of those receiving chlorhexidine wipes only 47% of the time, which “suggests that adherence may have been lower than reported by participants,” they write. “It is unclear how often chlorhexidine needs to be used in order to decrease foot complications.”
Roghmann and team also note that chlorhexidine resistance, as estimated by chlorhexidine minimum inhibitory concentrations from bacteria on the feet after trial completion, did not differ significantly between treatment groups.
The authors conclude: “Although there was no difference in outcomes between the 2 groups, the findings indicate that the intervention was well tolerated, and the trial provides important lessons for future studies on diabetic foot ulcer prevention.”
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