Background: Diabetic foot ulcers (DFUs) are main cause of hospitalizations and amputations in diabetic patients. Failure of standard foot care is the most important cause of impaired DFUs healing. Dakin's solution (DS; sodium hypochlorite) is a promising broad spectrum bactericidal antiseptic for DFUs management. Studies investigating the efficacy of using DS solution on DFUs healing process are scarce. Accordingly, this is the first evidence based randomized control trial study conducted to evaluate the effect of using diluted DS compared with the standard care in the management of infected DFUs. Methods: Randomized control trial study was conducted to assess the efficacy of DS in the management of infected DFUs. Patients were randomly distributed to control group (DFUs irrigated with normal saline) and intervention group (DFUs irrigated with 0.1% DS). Patients were followed for at least 24 weeks for healing, reinfection or amputations. In-vitro antimicrobial testing on DS was performed including determination of its minimum inhibitory concentration (MIC), minimum bactericidal concentration (MBC), minimum biofilm inhibitory concentration (MBIC), minimum biofilm eradication concentration (MBEC) and suspension test. Results: Replacing normal saline irrigation in DFU standard care with 0.1% DS followed by soaking the ulcer with commercial sodium hypochlorite (0.08 %) after patient discharge significantly improved ulcer healing (p< 0.001) and decreased number of amputations and hospitalizations (p< 0.001). The endpoint of death from any cause (RR 0.13; p = 0.029) and the amputation rate (RR 0.27; p<0.001) were also significantly reduced. The effect on ulcer closure (OR 11.9; p<0.001) was significantly enhanced in comparison to the control group. Moreover, DS irrigation for inpatients, significantly decreased bacterial load (p< 0.001), The in-vitro analysis results of DS were: MIC (1.44%), MBC (2.88%), MBIC (1.08%) and MBEC (2.87%). Conclusions: Compared with standard care, diluted DS (0.1%) was more effective in the management of infected DFUs. DS (0.1%) irrigation with debridement followed by standard care is a promising method in the management of infected DFUs.

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