Objective: To explore the clinical efficacy of compound Huangbai fluid for the treatment of diabetic foot ulcer (DFU). Method: The 252 patients with DFU were recruited from the Metabolic Diseases Hospital of Tianjin Medical University between March 2014 and April 2015. They were randomly divided into the experimental group (EG

n = 126) and control group (CG

n=126). The standardized wound treatment was used in both groups

however

the ulcer wounds in the EG were also rinsed and infiltrated with compound Huangbai fluid

while in the CG

normal saline was used for rinsing. After treatment for 8 weeks

the ulcer size

inflammation related indicators

total clinical efficiency and incidence of adverse events were compared with statistical analysis between two groups. Result: The 240 subjects completed this study (n=120 in each group). After treatment for 8 weeks

the EG was superior to CG in term of the reduction of ulcer size

reduction of inflammation related indicators(white blood cell

neutrophil

C-reactive protein

erythrocyte sedimentation rate)

and total clinical efficacy (P< 0.05). No significant differences in adverse events were found between two groups. There were no statistical differences in the reduction of ulcer size and inflammation related indicators were observed between ischemic and non-ischemic patients in EG. Conclusion: Compound Huangbai fluid has obvious clinical efficacy on ulcer wound healing and it is applicable to both ischemic and non-ischemic ulcer patients

so it is an effective and safe drug as an adjunctive treatment of DFU.