Objective: To assess the efficacy and safety of Tangzu Yuyang Ointment (TYO) for treatment of chronic diabetic foot ulcers.
Methods: Fifty-seven patients with chronic diabetic foot ulcers of Wagner's ulcer grade 1 to 3 were randomly assigned to the control group (29 cases) and the treatment group (28 cases). Patients in the control group received the standard wound therapy (SWT), while those in the treatment group received SWT plus TYO. The ulcer healing rate, the ulcer improvement rate and the incidence of adverse events were compared between the two groups. Totally 48 patients finished the final follow-ups and entered the data analysis.
Results: The ulcer improvement rate was 79.2% in the TYO group and 41.7% in the SWT group (P=0.017) at the 12th week, and 91.7% vs. 62.5% (P=0.036) at the 24th week. There was no statistical difference in the ulcer healing rate and the incidence of adverse events between the two groups at week 4, 12, and 24, respectively. The ulcer healing time was 96 +/- 56 days in the TYO group and 75 +/- 53 days in the SWT group, showing insignificant difference (P=0.271).
Conclusion: TYO plus SWT was more safe and effective than SWT alone in the treatment of chronic diabetic foot ulcers.