Biofilm detection-based wound management in diabetic foot ulcers: a randomised controlled trial

OBJECTIVE: This study aimed to investigate the effectiveness of wound blotting-guided biofilm management in diabetic foot ulcers (DFUs) and to compare it to standard of care (SoC). METHOD: This double-blinded, randomised controlled trial was conducted at an outpatient clinic in Pontianak City, Indonesia in September-November 2017 and June 2018-November 2019. Adults with diabetes with at least a two-week DFU located below the knee were included. Patients in the control group received SoC followed by the application of any appropriate dressings. Patients in the intervention group in addition to SoC also received additional wound cleansing according to the wound blotting result and antimicrobial dressing. Wound treatment was performed weekly for three weeks. Primary and secondary objectives were: the reductions in total depth; maceration; inflammation/infection; size; tissue type; type of wound edge; tunnelling/undermining (DMIST) score; and percentage of biofilm removal. RESULTS: A total of 162 participants were recruited. There were significant differences in the total DMIST score at week 3 (p<0.01) between groups and biofilm percentage reduction at week 1 (p=0.01) and week 2 (p=0.03). CONCLUSION: The findings of this RCT showed that the intervention could significantly improve DFU healing and maximise biofilm elimination, especially after two weeks of treatment. A further study with a longer period of intervention, such as 12 weeks, is suggested to further evaluate the effectiveness of this intervention.