Objective:To observe the clinical efficacy and safety of Chinese medicated diet based on routine therapy in the treatment of diabetic foot ulcer combined with hypoalbuminemia. Methods77 patients with diabetic foot ulcers and hypoproteinemia were randomly divided into the treatment group (39 cases) and control group (38 cases). Both groups were treated with routine therapy and diabetes diet. Additionally, the control group was treated with compound amino acid capsules and the treatment group was treated with Huangqi Zhuti Decoction, with a course of 1 month. The wound healing efficacy and medication safety were observed. The wound area, nutritional risk index (NRI) and serum nutriology related indexes such as total protein (TP), albumin (Alb), prealbumin (PA) and hemoglobin (Hb) were compared.  Results:①There were statistically significant differences on the levels of TP, Alb, PA and Hb in the treatment group between treatment before and after (P<0.05). After treatment, the levels of TP, Alb, PA and Hb in the treatment group were obviously higher than those in the control group (P<0.05). ②There was statistically significant difference on the NRI level in the treatment group between treatment before and after (P<0.05). After treatment, the NRI level in the treatment group was obviously higher than that in the control group (P<0.05). ③There was statistically significant difference on the wound area in both groups between treatment before and after (P<0.05). After treatment, the wound area in the treatment group was obviously smaller than that in the control group (P<0.05). ④The total effective rates of wound healing were 82.1% in the treatment group and 52.6% in the control group, the wound healing efficacy of the treatment group was obviously better than that of the control group, with statistically significant difference (P<0.05). ⑤There were no statistically significant differences on the levels of triacylglycerol, total cholesterol, fasting blood glucose and postprandial 2 h blood glucose in both groups between treatment before and after (P>0.05). There were also no statistically significant differences on the levels of liver and kidney function indexes including total bilirubin, direct bilirubin, alanine transaminase, aspartate aminotransferase, creatinine, urea nitrogen and uric acid in both groups between treatment before and after (P>0.05).  Conclusion:Chinese medicated diet based on the routine therapy in the treatment of diabetic foot ulcer combined with hypoalbuminemia can obviously improve the nutritional status of patients, and promote the wound healing, which shows good safety and no effects on the blood glucose, blood lipid and liver and kidney function.