Innovative study of modified varicose veins in lower extremities combined with Zizhu ointment for external use in the treatment of venous ulcer of lower extremities

Phase 1

Recruiting

• Conditions: Venous ulcer of lower extremities

• Registration Number: ITMCTR2000003999
• Lead Sponsor: Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet the diagnostic criteria, CEAP grading is C5-C6;
2. Male or female between 18 and 85 years old;
3. Patients and their family members signed informed consent for treatment.
Only those patients who meet all above-mentioned requirements can be included.

Exclusion Criteria

1. Accompanied by arterial ischemic disease caused by ulcers such as thromboangiitis obliterans, diabetic foot, arteriosclerosis obliterans;
2. Patients with serious medical diseases and serious primary diseases of the blood system, as well as patients with mental diseases and tumors; Pregnant and lactating women;
3. Uncontrolled diabetes patients;
4. Patients with a history of deep venous thrombosis and preoperative venous color ultrasound examination of lower extremities;
5. To the drug allergy is not suitable for the treatment of patients;
6. Patients with underlying diseases can not tolerate surgery;
7. Women who are pregnant or breastfeeding and women who plan to become pregnant during the study period;
8. According to the judgment of researchers, there are other circumstances that reduce the possibility of enrollment or complicate enrollment, and the working environment is constantly changing, which may easily cause loss of follow-up.
Anyone who meet one of the above criteria are excluded.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lcer healing time;Ulcer healing rate;

Secondary Outcome Measures

Name	Time	Method
ower extremity venous color doppler ultrasound;Abscess culture and fungus on ulcer surface;Ulcer surface PH value;hepatorenal function;A numerical ranking of pain levels;Quality of life questionnaire for patients with venous leg ulcers;blood routine examination;