To observe the effects and mechanism of Huang's butter gauze on diabetic foot treatment based on the theory of lung and spleen.Methods:A total of 60 cases in accordance with the inclusion criteria of diabetic foot (I-IV) admitted in the first hospital of traditional Chinese medicine diabetes clinics from June 2015 to May 2017 year were randomly divided into treatment group and control group, with 30 cases in each group.The control group was received conventional treatment of diabetes and Mecobalamin Capsules, and the treatment group was received Huangshi oil gauze application based on control group.The changes of clinical syndromes of traditional Chinese medicine were observed; fasting blood glucose (FBG), 2 h postprandial blood glucose (2 hPBG), glycosylated hemoglobin (HbA1c) were evaluated before and after treatment in patients with diabetes; ankle brachial index determination (ABI) and sensory examination of patients with diabetic foot threshold were measured.Results:1) There was no statistically significant difference in TCM syndromes of diabetic foot between the two groups before treatment (P>0.05).After treatment, Huang's butter gauze decreased the TCM syndrome score (P<0.05), and it was better than that of the control group (P<0.05).2) Compared with before treatment, the blood glucose of the two groups decreased (P<0.05), and there was no statistically significant difference in FBG, 2 hPBG and HbAlc between the two groups (P>0.05).3) After treatment, the ABI treatment group and the control group were higher than before treatment (P<0.05), and the treatment group was superior to the control group (P<0.05).4) After treatment, the sensory threshold of the two groups decreased (P<0.05), and the sensory threshold of the treatment group was lower than that of the control group (P<0.05).Conclusion:The lung and spleen theory found Huang's butter gauze for the treatment of diabetic foot can improve the TCM symptoms based on its therapeutic mechanism, which may be related to the decrease of ABI and sensory thresholds, and improve the DF patients with distal microcirculation and nerve fiber conduction on the skin.