Clinical Study for the 'same disease treated by different remedies' Comprehensive Scheme in the Treatment of Diabetic Foot Disease
- Conditions
- Diabetic foot disease
- Registration Number
- ITMCTR2000002988
- Lead Sponsor
- onghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Those who met the diagnostic criteria of Western medicine;
2. Wagner grade II-IV;
3. Those who met the diagnostic criteria of traditional Chinese medicine;
4. Aged 18-80 years old, male and female;
5. Those who had diabetic foot wound area (>1.2) and < 25.2 after debridement;
6. Those who had informed consent, signed informed consent.
1. Those who did not meet the diagnostic criteria and inclusion criteria; 2. Severe primary diseases, such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, psychiatric patients, cancer or AIDS patients; 1. Abnormal serum creatinine > 1.5 times the upper limit of normal value, proteinuria >+(>30mg/dl/100ml); 2. ALT > 1.5 times the upper limit of normal value;
3. arrhythmia of clinical significance;
4. pregnant or lactating women, allergic constitution;
5. patients with severe infection and critical condition;
6. patients with diabetic foot wound area after debridement (> 25cm2, or 2);
7. patients do not meet the inclusion criteria, do not use drugs according to regulations, can not judge the efficacy, or incomplete data affect the efficacy or safety judgment. According to the judgement of the researchers, other medical histories, such as frequent changes in working environment, which can reduce the possibility of enrollment or complicate enrollment, are liable to lead to loss of follow-up;
8. subjects who are participating in other drug clinical studies.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound healing rate;
- Secondary Outcome Measures
Name Time Method Wound healing rate;Rate of wound decay;TCM syndrome;Wound healing time;Amputation rate;Time of wound decay;Toe amputation rate (disability rate);mortality;Recurrence rate;