Diabetic foot disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healing rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound healing time;Wound healing rate;Time of wound decay;Rate of wound decay;Amputation rate;Toe amputation rate (disability rate);mortality;TCM syndrome;Recurrence rate; | — |
Countries
China
Contacts
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine