Clinical effect analysis and mechanism study on Qufu Shengjidan fo diabetic foot ulcer
- Conditions
- Diabetic foot ulcer
- Registration Number
- ITMCTR2000003244
- Lead Sponsor
- Chongqing Orthopaedic Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Aged 18-75 years, gender unlimited;
2. Patients diagnosed with diabetes mellitus and ulceration, which accords with the classical Wagner grading method of grade 1-3;
Grade 0: no open lesions, but belongs to high-risk foot; Grade 1: superficial ulcer with skin penetration; Grade 2: deeper ulcer, including ulcers of joints and tendons; Grade 3: deep ulcer, abscess formation, tendon ligament tissue damage; Grade 4: local gangrene and bone destruction; Grade 5: total foot gangrene.
3. Patients who did not use immunosuppressive agents, or those whose doses of immunosuppressive agents remained unchanged recently;
4. Sign the informed consent.
1. diabetic ketoacidosis, non-ketotic hyperosmolar coma patients;
2. women in lactation and pregnancy;
3. patients with allergic history or recent allergic diseases to multiple drugs;
4. patients with severe cardiopulmonary disease, cirrhosis, diabetic nephropathy or more, whose condition is still unstable after active medical treatment;
5. ulcers caused by malignant tumors;
6. patients with psychiatric diseases and ignoranceThose who can not express exactly;
7. those with poor compliance;
8. those who have participated in other clinical trials of new drugs in the last three months.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of ulcer area;Clinical efficacy evaluation;Determination of inflammation-related indicators;
- Secondary Outcome Measures
Name Time Method Observation of histochemical staining of granulation tissue;