Can the use of a topical antifungal nail lacquer reduce risk for diabetic foot ulceration? Results from a randomised controlled pilot study.

The purpose of this study was to determine whether the routine use of a topical antifungal nail lacquer (AFL) could reduce the risk for ulceration by theoretically increasing the frequency of patient self-inspection. In this randomised controlled trial, 70 persons at high risk for diabetic foot ulceration were enrolled into a preventative care program involving daily self-inspection with the possible use of an AFL (ciclopirox 8%) versus self-inspection instructions alone (NAFL). Patients were followed for 12 months or until ulceration. Using an intent to treat analysis, there was no significant difference in proportion of persons ulcerating in the AFL versus the NAFL groups (5.9% versus 5.6% P = 0.9). There was also no difference in the number of unexpected visits (P = 0.2) or missed appointments (P = 0.7) between treatment arms. Interestingly, while there was no difference in proportion of patients with clinically diagnosed hyperkeratosis or tinea pedis on entry into the study (P = 0.2), a significantly lower proportion of AFL patients had a clinical diagnosis on study termination (52.9% versus 77.8% P = 0.03, OR = 1.7, 95% confidence interval = 1.1-2.7). The results of this study suggest that there may be no immediate prophylactic benefit through the use of AFL to prevent wounds. The incidental finding of a potential reduction in hyperkeratosis and tinea pedis is a compelling one and may deserve further investigation.