Clinical study for xiaoduyuji plaster by traditional Chinese medicine in the treatment of diabetic foot
- Conditions
- diabetic foot
- Registration Number
- ITMCTR2200005929
- Lead Sponsor
- orth China University of Science and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) diabetes foot (limb gangrene) examination method and diagnostic criteria in line with the American Diabetes Association Diabetes Prevention guideline (2010 Edition) are in line with diagnostic criteria. (2) 40 ~ 90 years old; (3) the duration of diabetes mellitus was 5~20 years, and the duration of ulcer (gangrene) was 1~10 years. (4) Wagner classification I ~ III (grade I: there are open lesions on the skin of the extremities. Blisters, blood bubbles, corns, or frostbite, scald are superficial ulcers of the skin caused by other skin operations, but the lesions have not yet affected the deep tissue. Grade II: infected lesions to invade the deep muscle tissue. There are often cellulitis, multiple purulent foci, sinus formation or infection, which expand along the muscle space, resulting in penetrating ulcers on the dorsum of the foot, with more purulent secretions, but the tendons and ligaments have not been damaged. Grade III: muscle Destruction of tendon and ligament tissue, fusion of cellulitis, formation of large purulent cavity, increase of purulent secretion and necrotic tissue, but bone destruction is not obvious); (5) All treatment measures and treatments were informed to patients and their families, and informed consent was signed.
(1) Does not meet the above diagnostic and inclusion criteria;
(2) If the limb is completely necrotic after admission, it needs amputation or cannot be treated according to the regulations.
(3) Combined with cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system diseases, and mental diseases
And patients with malignant tumors;
(4) Patients with mental disorders or serious psychological disorders;
(5) Patients who had taken painkillers and sedatives within one week before treatment;
(6) Patients who are participating in other clinical trials.
Note: any one of the above shall be excluded.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method