Prospective randomized controlled study of a Chinese herbal medicine compound Tangzu Yuyang Ointment for chronic diabetic foot ulcers: a preliminary report.

Abstract Aim of the study The purpose of this study was to evaluate the efficacy and safety of a topical Chinese herbal medicine (CHM) compound Tangzu Yuyang Ointment (TYO) for treatment of chronic diabetic foot ulcers. Materials and methods This multi-center, prospective, randomized, controlled and add-on clinical trial was conducted at seven centers in the China mainland. Fifty-seven patients with chronic diabetic foot ulcers of Wagner's ulcer grade 1–3 were enrolled in this study. Patients who were randomly assigned to the control group ( n  = 28) received standard wound therapy (SWT), whereas those randomized to the treatment group ( n  = 28) received SWT plus topical TYO. Only 48 patients who finished 24 weeks of observations were entered for data analysis. Results The TYO and SWT groups were comparable for baseline characteristics. Ulcer improvement was 79.2% in the TYO group and 41.7% in the SWT group ( P  = 0.017) at 12 weeks, and 91.7% vs. 62.5% ( P  = 0.036) at 24 weeks. The number of ulcers that were completely healed at 4, 12 and 24 weeks was similar in both groups, as were the numbers of adverse events. Healing time was 96 ± 56 days ( n  = 19) in the TYO group and 75 ± 53 days ( n  = 14) in the SWT group ( P  = 0.271). Conclusion TYO plus SWT is more effective than SWT in the management of chronic diabetic foot ulcers and has few side-effects.