Efficacy and Safety of the Traditional Chinese Medicine Yunnan Baiyao in the Treatment of Diabetic Foot Ulcers: a Multicentre, Randomised Clinical Trial.

Diabetic foot ulcers (DFUs) constitute an increasing clinical challenge, driven by the escalating prevalence of diabetes and the paucity of effective therapies. This multicentre, randomised, open-label, blinded-endpoint trial investigated the efficacy and safety of Yunnan Baiyao (YNBY), a traditional Chinese medicine, as an adjunctive therapy for DFUs. Patients with DFUs (Wagner Grade 3 or 4) from three hospitals were randomised 2:2:1 to YNBY powder, YNBY ointment and control groups, all receiving standard of care. A total of 117 patients completed the trial. The 2-week percentage of wound area reduction (PWAR) was significantly higher in YNBY powder (61.5%) and YNBY ointment (70.0%) groups than that in the control group (46.4%, p < 0.01). The 1-week PWAR was almost doubled in the YNBY powder group (36.1%) and the YNBY ointment group (42.9%) relative to the control group (19.5%, p < 0.05). The percentage of complete healing within 8 weeks (control group, 25.0%; powder group, 54.2%; ointment group, 61.9%) did not reach statistical significance. No significant differences were observed between the YNBY powder and ointment groups. The adjunctive use of YNBY powder or ointment with standard therapy significantly accelerates wound closure. This effective, inexpensive, easy-to-apply traditional medicine can serve as an effective adjunct to standard DFUs care. Trial registration: https://clinicaltrials.gov/, NCT06197412 (Registration Date: 12/17/2023).