(I) Technical Field This invention belongs to the field of traditional Chinese medicine surgery and involves the field of traditional Chinese medicine, specifically a topical ointment formulation for the treatment of diabetic foot ulcers. The specific application scope includes chronic, refractory skin ulcers such as diabetic foot ulcers. It has the function of '煨脓长肉' to promote liquefaction of necrotic tissue, stimulate granulation tissue growth on the wound surface, and accelerate the healing of gangrene. (II) Main Technological Innovation Content 1. Diabetic foot is a serious chronic complication of diabetes. Faced with the difficulties of difficult treatment, long duration, high recurrence rate, and heavy economic burden of diabetic foot, the project team selected an empirical formula with outstanding clinical efficacy in treating this disease. In accordance with the relevant requirements of the 'Administrative Measures for the Registration of Traditional Chinese Medicine' issued by the SFDA, a combination of clinical and modern pharmacological research was adopted to develop the Zizhushu Ointment through methods such as formula screening, quality control of medicinal materials, and optimization of production technology. Relevant process flows and quality control standards were also established. The clinical application has confirmed that the drug has the effects of clearing heat and detoxifying, promoting suppuration and necrotic tissue removal to promote tissue regeneration, and accelerating the healing of ulcers. At the same time, it has good social benefits. The main technical innovations of this project are as follows: 1. Completed the transformation of Zizhuru Ointment from clinical experience medication to modernized traditional Chinese medicine preparation. 1.1 Completed the scientific analysis and screening simplification of the traditional Chinese medicine components of Zizhuru Ointment, established a stable process flow and quality control standards. By adopting orthogonal experimental methods for drug screening, pharmaceutical quality control, and process development optimization, a Zizhuru Ointment composed of six traditional Chinese medicines, namely cinnabar, lithospermum, astragalus, dragon's blood, donkey-hide gelatin, and borneol, was developed, and the drug production process flow standards were established. 1.2 Established the pharmaceutical quality control system for Zizhuru Ointment, completed and passed the drug pilot-scale trial and safety evaluation. Established the quality control standards for Zizhuru Ointment: The mercury content in cinnabar, as well as the qualitative and quantitative detection of lithospermum and dragon's blood were carried out using more than two methods. The pilot production of Zizhuzhu ointment was completed at the GMP certified factory of Wuhan Yiling Pharmaceutical Group Co., Ltd. The Shanghai Institute for Food and Drug Control was commissioned to complete the safety tests such as skin irritation, sensitization, and acute toxicity of Zizhuzhu ointment, as well as stability studies, confirming the safety and formulation stability of Zizhuzhu ointment. 2. The establishment of an animal model for 'wet' diabetic foot ulcers and the pharmacodynamic animal experiments of Zizhuzhu ointment were completed. A standardized, streamlined process was established for 'high-fat diet feeding - low-dose streptozotocin injection - thermal injury instrument manufacturing model - bacterial strain subcutaneous infection - diabetic foot ulcer', establishing three types of wet rat models. On this basis, pharmacodynamic studies of Zizhuzhu ointment (2 times, standard dose, 1/2 times, base) were completed. The results show that the standard Zhushu ointment can promote wound healing in diabetic foot, stimulate granulation tissue growth, and enhance local angiogenesis and epithelial growth. 3. The mechanism of Zhushu ointment in promoting wound healing has been studied through the regulation of fibroblast and vascular endothelial cells via the NF-κB p65, JNK/PI3K signaling pathways. The results indicate that Zhushu ointment negatively regulates inflammatory factors such as NF-κB in local tissue, positively regulates proteins involved in skin tissue injury repair such as PI3K, JNK, Ecadherin, VEGF, etc., and stimulates angiogenesis in skin to promote wound healing. 4. The clinical efficacy of Zhushu ointment in treating chronic refractory skin ulcers such as diabetic foot has been re-evaluated. Through clinical randomized controlled trials on chronic refractory ulcers such as diabetic foot, The results show that Zizhuru Ointment can effectively alleviate the pain, odor, skin temperature, and granulation growth of the ulcer surface in patients, promote the healing of chronic skin ulcers, and has a definite therapeutic effect. (III) Intellectual Property Rights and Application Promotion This project is based on clinical research for the development of new drugs, truly achieving original innovation and independent intellectual property rights. The project has applied for 9 invention patents, with 2 having been granted. It has won the Silver Award in the 27th Shanghai Excellent Invention Selection Competition from the Health and Family Planning System. More than 20 related academic papers have been published. Six master's degree students have been trained. One third-batch national outstanding TCM clinical talent has been cultivated. It has also been applied in several tertiary-level A hospitals in Shanghai.