Diabetic Foot Ulcers
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Conform to the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of diabetes Foot: 1) Have a history of diabetes; 2) Symptoms of malnutrition such as ulcers and gangrene on the feet; 3) Lower limb vascular disease associated with diabetes; 4) Combined with diabetes peripheral neuropathy; 5) Wagner grading 1-3 levels; (2) The course of diabetes is more than one year and the glycosylated hemoglobin is less than 8%; (3) Age range of 30 to 80 years old; (4) The patient signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with end-stage diabetes nephropathy and diabetes ketoacidosis; (2) Patients with combined ulcer malignancy and severe infection in the extra foot area; (3) The patient's condition is critical and requires amputation; (4) With other malignant tumors; (5) Patients with severe heart brain liver kidney digestive tract and hematological diseases; (6) Individuals with mental or neurological disorders who are unable to take medication on time or who abuse drugs and other substances; (7) Screening participants who have participated in any other clinical trials (enrolled and have used the investigational drug) within the past 3 months; (8) Pregnant lactating women and those planning to conceive in the near future; (9) Known or suspected allergy to the test drug; (10) Researchers believe that other reasons are not suitable for clinical trial participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer area of diabetes foot;Clinical efficiency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Basic fibroblast growth factor;serum amyloid A;Traditional Chinese Medicine Symptom Score;Serum hs-CRP;Vascular endothelial growth factor; | — |
Countries
China
Contacts
Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine