[Translation] A Phase II/III seamlessly designed, randomized, double-blind, parallel-group, excipient-controlled study to evaluate the efficacy and safety of Xiangleitang Foot Cream in the treatment of diabetic foot wound ulcers of Wagner grade II
究主要目的是在第一阶段(II期)研究中探索每天局部使用两次香雷糖足膏与辅料相比,用于治疗Wagner II级糖尿病足部伤口溃疡的疗效,进而在第二阶段(III期)研究中评估每天局部使用两次香雷糖足膏与辅料相比,用于治疗Wagner II级糖尿病足部伤口溃疡的疗效。
其他目的是研究香雷糖足膏治疗糖尿病足达到溃疡完全愈合的时间、在生活质量上的变化、愈合后的复发率及安全性。
[Translation] The main objectives of the study were to explore the efficacy of topical Xiangleitang foot cream applied twice daily compared with excipients for the treatment of Wagner grade II diabetic foot wound ulcers in a phase I (Phase II) study, and then to evaluate the efficacy of topical Xiangleitang foot cream applied twice daily compared with excipients for the treatment of Wagner grade II diabetic foot wound ulcers in a phase II (Phase III) study.
Other objectives were to study the time to complete healing of diabetic foot ulcers, changes in quality of life, recurrence rate after healing, and safety of Xiangleitang foot cream.