Chlorhexidine vs routine foot washing to prevent diabetic foot ulcers: a randomized clinical trial

We conducted the Preventing Diabetic Foot Ulcers through Cleaner Feet Trial as a single center, double blind (participant, outcome assessor), placebo-controlled parallel group, Phase 2b randomized clinical trial at the Baltimore Veterans Affairs (VA) Medical Center. Our objective was to evaluate the effect of daily foot care with wipes containing 2% chlorhexidine compared to daily foot care with wipes containing soap and water and no chlorhexidine for 1 year on the risk of developing new foot complications (including chronic foot ulcer, foot infection, or foot amputation) in Veterans with diabetes. We also aimed to determine if the chlorhexidine intervention increased chlorhexidine resistance in diabetic foot infection pathogens.Trial Registration: ClinicalTrials.gov Identifier: NCT03503370Dataset 1 – Demographics and health characteristics for all enrolled participants. Also includes treatment group and primary outcome data for randomized participants.Dataset 2 – Data for secondary outcome for randomized participantsDataset 3 – All adverse events