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Study on TCM precise external treatment of refractory diabetic foot ulcer (Wagner grade 3-5)

Phase 1
Recruiting
Conditions
Diabetic foot ulcer
Registration Number
ITMCTR2000003745
Lead Sponsor
Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Patients who meet the diagnostic criteria of diabetes mellitus;
2. Patients who met Wagner's grade 3-5 classification of diabetic foot;
3. Patients aged 45-85 years old;
4. Patients who agree to participate in randomized controlled trials and sign informed consent form by themselves or their guardians.
Only those who meet the above requirements can be included.

Exclusion Criteria

1. Pregnant or lactating women;
2. Patients with diabetic ketosis, ketoacidosis and severe infection in recent 3 months;
3. Patients with serious heart, liver and kidney complications, or with other serious primary diseases and mental patients;
4. Patients with neurovascular diseases caused by other reasons;
5. Patients who are allergic to the related drugs in the treatment plan and are not suitable for receiving the treatment plan;
6. Patients who are participating in other clinical trials;
7. Other situations that the researcher thinks are not suitable for the group.
Those who meet the above requirements are excluded.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
amputation rate;clinical efficacy;healing rate;
Secondary Outcome Measures
NameTimeMethod
ipid metabolism index;Glucose metabolism index;Lower limb CTA or MRA;Lower extremity artery ultrasound;Evaluation index of diabetic foot typing;Bacterial and fungal culture and drug susceptibility;Ankle-brachial ratio index;symptoms and signs;Quality of Life scale;Diabetic neuropathy and test scores;Foot X ray;Evaluation index of diabetic foot immunology;
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