[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].
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. To this end, 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
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.


CONCLUSIONS
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.


BACKGROUND
The research program was registered in the Chinese Clinical Trial Registry in both English and Chinese in June 2011.


BACKGROUND
ChiCTR-TRC-11001365.
Department of Traditional Chinese Medicine Surgery, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.
Yun-fei
YF
Wang
Hua-fa
HF
Que
Jie-nan
JN
Xu
Han-jun
HJ
Tang
Huan-yu
HY
Xiang
Xiao-dong
XD
Liu
Zhen
Z
Zhang
Jie
J
Xing
Liang
L
Shen
Wei
W
Shan
An-min
AM
Liu
Lian-yin
LY
Qiu
Da-yi
DY
Deng
Dan
D
Gao
D002985:Clinical Protocols; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use; D006801:Humans; D035002:Lower Extremity / Q000473:pathology*; D008516:Medicine, Chinese Traditional / Q000379:methods*; D008517:Phytotherapy; D011446:Prospective Studies; D014456:Ulcer / Q000188:drug therapy / Q000628:therapy*
D004365:Drugs, Chinese Herbal