diabetic foot ulcers
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Comply with the quality control standard of single disease of diabetic foot gangrene and the diagnostic standard of non-ischemic diabetic foot in Modern Diabetes Diagnosis and Treatment approved by Shanghai Municipal Science and Technology Commission; and comply with the diagnostic standard of Chinese medicine evidence and symptoms. (2) The age is 40 to 80 years old; (3) Patients' ankle-brachial index is within the required range: 0.8 < ankle-brachial index < 1.3; (4) All patients signed an informed consent for treatment.
Exclusion criteria
Exclusion criteria: (1) Age 80 years; (2) Those with ischemic diabetic foot ulcers; (3) Those with severe hepatic or renal insufficiency defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) =2* upper limit of normal (ULN) as defined by the Center or blood creatinine (Scr) >1.5*UNL; (4) Patients with malignant tumors or psychiatric disorders; (5) Those treated with surgical or interventional angioplasty; (6) Those who had participated in other clinical trials 4 weeks prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer healing rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Chinese Medicine Symptom Score;VAS score;Serum inflammatory factors NLRP3 IL-1ß IL-18; | — |
Countries
CHINA
Contacts
Shuguang Hospital Affiliated Shanghai University of Traditional Chinese Medicine