Designs
trauma, DFIs
DIABETIC FOOT INFECTIONS
A multicenter RCT on diabetic foot infections (DFIs) was taken as an example. This trial evaluated the efficacy and safety of a Chinese patent medicine. Patients with DFI, aged between 18 and 75 years, and IDSA/IWGDF grade 2 were included [There is a greater risk of using a placebo control for patients in this trial. Furthermore, placebos are challenging to match the investigational drug in terms of color, texture, and odor [To ensure the objectivity and consistency of the test results, using objective evaluation methods to evaluate the efficacy indicators is necessary. We envisioned a blinded evaluation of efficacy indicators using a center-reading blinded method. The center-reading blinded method refers to using a digital camera to take pictures of the condition of the subject’s foot and using the image analysis software ImageJ to analyze the trauma area. We compared the differences between unblinded and center-reading blinded evaluations to investigate whether this method better reflects an accurate picture of efficacy. In addition, other perspectives were collected at the end of this study, including with those involved in designing and conducting the recent blinded evaluation trial.