Postoperative edema of primary venous insufficiency of lower extremity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, sex is not limited; 2. CVI patients with primary venous insufficiency of lower extremity with symptoms of C2-C5; 3. Ultrasound / CTV / MRV / venography confirmed the patency of deep vein of lower extremity; 4. The affected limb received CVI for the first time and has postoperative edema; 5. Understand and agree to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. There were chronic venous reflux disorders in the affected limb, such as iliac vein compression, deep vein thrombosis syndrome, etc; 2. The limb was complicated with acute DVT or had a history of DVT in the past; 3. CVI operation was not performed; 4. CVI recurred after operation; 5. There were lower extremity edema caused by cardiogenic, hepatogenic and nephrogenic lymphatic reflux disorders; 6. Other anti edema drugs were used within 1 month; 7. According to the researcher, it may affect the patients' participation in the trial or affect the outcome of the trial, such as severe gravity function, liver function, renal insufficiency, etc; 8. Those who are not suitable to participate in the clinical trial, such as limb ulcer and infection; 9. Known to be allergic or intolerant to the components of the study drug; 10. Participated in other clinical trials within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree of swelling relief: the change of leg circumference on the 21st day of treatment compared with baseline was measured; | — |
Secondary
| Measure | Time frame |
|---|---|
| The degree of swelling relief: the change of leg circumference on the 10th?30th day of treatment compared with baseline was measured;The degree of swelling relief: the ankle circumference was measured on the 10th, 21st and 30th days after treatment compared with baseline;VCSS score;VAS score;AVVQ (Aberdeen Varicose Vein Questionnaire);Safety evaluation; | — |
Countries
China
Contacts
The Ninth People's Hospital Affiliated to medical school of Shanghai Jiaotong University