[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 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.

[Therapy mainly for strengthening healthy energy to promote blood circulation in treating 112 diabetic patients with gangrene].

OBJECTIVE: To evaluate the effects of the therapy mainly for strengthening healthy energy to promote blood circulation in treating diabetic patients with gangrene. METHODS: A series of 112 diabetic patients with gangrene were investigated before and after treatment in the changes of wounds, clinical symptoms and quality of life. RESULTS: Fifty-eight cases were cured, 12 cases showed response, 36 cases improved, and 6 cases failure of treatment. The total obvious effect rate was 62.5% (70/112) and the amputation rate was 8.9% (10/112). The 104 diabetic cases of three-stage gangrene were classified into grade I, II and III. The total effect rates of the diabetic cases of grade I, II and III were 83.3% (30/36), 55.6% (35/63) and 20% (1/5), and the amputation rates were 0%, 12.7% (8/63), and 40% (2/5) respectively. After the treatment, the clinical symptoms, gangrene number, gangrene area and gangrene depth were obviously improved (P<0.05), and the quality of life was obviously improved (P<0.01), especially in physical condition, emotional well-being and therapeutic effects on patients (P<0.05). CONCLUSION: Strengthening healthy energy to promote blood circulation is effective in treating diabetic patients with gangrene.