Comparison of 4, 8, and 12 week screening and foot care frequencies in persons in remission: The DIATIME comparative efficacy study – A randomized clinical trial

AIMS: This study aimed to evaluate the clinical efficacy of 1, 2, and 3 months-based screening periods for the prevention of plantar DFUs in patients in remission. METHODS: A randomized, three-arm, controlled trial was conducted in 148 patients at high - risk in remission with a healed plantar foot ulcer. For the three treatment groups, the procedures were the same; the only difference was the screening timeframe: group 1, 4 weeks; group 2, 8 weeks; and group 3, 12 weeks. Primary outcome measure was the percentage of participants with plantar recurrence by the 1-year follow-up period. RESULTS: During the 12-month follow-up period, 50 participants (33.8 %) experienced a recurrence. We observed that participants in the 12-weeks group experience DFU recurrence significantly more frequently (n = 27, 46 %) than the 4-weeks (n = 18, 18.4 %) and 8-weeks (n = 14, 28.6 %) groups (P < 0.001). Ulcer survival curves significantly differed between the study groups (log-rank test, P < 0.001). In the logistic regression model, allocation was the only variable associated with ulcer recurrence during the 1-year follow-up period (P < 0.001, 95 % confidence interval:1.509-4.001). CONCLUSIONS: This trial found superior clinical efficacy in preventing plantar recurrence rates with the 4-weeks screening period compared to 8 and 12 weeks. This trial was registered at Clinicaltrials.gov (identifier ID NCT06143215) within the Unique Protocol ID name of the Diatime randomized controlled clinical trial.