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. Crown Copyright Â
RCT Entities:
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. Crown Copyright Â