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Prospective randomized controlled study of a Chinese herbal medicine compound Tangzu Yuyang Ointment for chronic diabetic foot ulcers: a preliminary report |
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| Authors: | Li Shufa Zhao Jianyong Liu Jianping Xiang Fei Lu Debin Liu Baoying Xu Jing Zhang Huimin Zhang Qian Li Xianwen Yu Richeng Chen Mingjun Wang Xia Wang Ye Chen Bing |
| Institution: | a Department of Endocrinology, Southwest Hospital, Third Military Medical University, Chongqing, China b Department of Endocrinology, Guiyang First People''s Hospital, Guiyang, China c Department of Normal Surgery, Guiyang First People''s Hospital, Guiyang, China d Center of Evidence-Based Medicine, Beijing University of Chinese Medicine, Beijing, China e Department of Endocrinology, The Second Affiliated Hospital of Guiyang Medical College, Kaili, China f Department of Endocrinology, Affiliated Hospital of Zunyi Medical College, Zunyi, China g Department of Endocrinology, People''s Hospital of Guizhou Province, Guiyang, China h Department of Endocrinology, The Fourth People''s Hospital of Guiyang City, Guiyang, China i Department of Endocrinology, No. 44, Hospital of Chinese People''s Liberation Army, Guiyang, China j The Key Laboratory of Chemistry for Natural Products, Guizhou Province and Chinese Academy of Science, Guiyang, China |
| Abstract: | Aim of the studyThe 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 methodsThis 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.ResultsThe 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).ConclusionTYO plus SWT is more effective than SWT in the management of chronic diabetic foot ulcers and has few side-effects. |
| Keywords: | TCM traditional Chinese medicine TYO Tangzu Yuyang Ointment CHM Chinese herbal medicine SWT standard wound therapy BMI body mass index SD standard deviation DNS diabetic neuropathy symptom NCV nerve conduction velocity ABI ankle-brachial index HPLC high performance liquid chromatography HbA1c glycated haemoglobin ITT intention-to-treat PDGF platelet-derived growth factor VEGF vascular endothelial-derived growth factor |
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