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Journal of Chinese Integrative Medicine ›› 2012, Vol. 10 ›› Issue (2): 166-175.doi: 10.3736/jcim20120207

• Study Protocol • Previous Articles     Next Articles

Assessment of external methods of traditional Chinese medicine in patients with chronic ulcer of the lower extremities: study protocol of a multicenter, randomized, parallel-group, prospective trial

Wang Yun-fei,Que Hua-fa(),Xu Jie-nan,Tang Han-jun,Xiang Huan-yu,Liu Xiao-dong,Zhang Zhen,Xing Jie,Shen Liang,Shan Wei,Liu An-min,Qiu Lian-yin,Deng Da-yi,Gao Dan   

  1. Department of Traditional Chinese Medicine Surgery, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
  • Received:2011-08-28 Accepted:2011-09-18 Online:2012-02-20 Published:2018-10-09

BACKGROUND: Chronic ulcer of the lower extremities amounts for a grave and serious problem for public health. Western medicine focuses on controlling infection, improving blood circulation, surgical debridement, skin grafting, etc, but there are bottlenecks in the treatment. Traditional Chinese medicine (TCM) has a long history and a legacy of sound clinical efficacy in this area. TCM has developed a unique, effective external theory, and a large number of topical prescriptions and external technology. Through this research, a safe and effective treatment protocol of TCM for chronic ulcer of the lower extremities can be formed. During China’s “Eleventh Five-Year” Plan, special research committees and projects on TCM external treatments and external technologies were established. This study on ulcer of the lower extremities constitutes one of the major research topics.
METHODS AND DESIGN: Clinical information of patients with chronic ulcer of the lower extremities will be first collected in a large, multicenter, epidemiological survey. Concurrently, a large multicenter, randomized, parallel-group, prospective study will be launched based on evidence-based medical principles to evaluate the efficacy and safety of external methods for removing carrion, dissolving stasis, reinforcing deficiency and promoting tissue regeneration. The evaluated indexes will include the wound healing percentage for primary outcome, wound healing time, wound healing rate, time and rate of removal of necrotic tissue, and TCM syndromes for secondary outcomes and routine blood test, routine urine test, liver and kidney function, blood mercury content and finally urine mercury content for adverse events.
DISCUSSION: In this trial, the authors will evaluate the efficacy and safety of external methods for removing carrion, dissolving stasis, reinforcing deficiency and promoting tissue regeneration in cases of chronic ulcer of the lower extremities for standardizing external therapy of TCM for treatment of this condition, and establishing the clinical assessment system for TCM.
TRIAL REGISTRATION NUMBER: The research program was registered in the Chinese Clinical Trial Registry in both English and Chinese in June 2011. Registration number: ChiCTR-TRC-11001365.

Key words: lower extremities, ulcer, chronic, clinical protocol, traditional Chinese medicine, multicenter study, prospective study, randomized controlled trial

Table 1

Treatment and control measures"

Stage Treatment measures
Chinese medicine treatment group Western medicine control group
Removing carrion Routine wound dressing change Routine wound dressing change
Debridement Debridement
Fumigation and washing with Chinese herbal medicine for clearing heat, dispersing dampness and detoxifying Vaseline gauze
Jiuyi Powder
Wet packing with Chinese herbal medicine for clearing heat, dispersing dampness and detoxifying
Promoting granulation Routine wound dressing change Routine wound dressing change
Fumigation and washing with Chinese herbal medicine for reinforcing deficiency, activating blood and promoting granulation Basic fibroblast growth factor agent

Shengji Powder
Wet packing with Chinese herbal medicine for reinforcing deficiency, activating blood and promoting granulation
Bandaging therapy
Wearing elastic stockings or binding with elastic bandages

Figure 1

Technical route of this randomized therapeutic protocol"

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