venous reflux obstruction in lower limbs
Conditions
Interventions
Control Group:placebo
Sponsors
The Affiliated Hospital of Nanjing University Medical School, Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Aged from 18 to 70 years old, no gender limitation; 2) Patients with CVI diagnosed by the researcher, and under conservative treatment with CEAP = grade 4; 3) Doppler ultrasound or CTV confirmed the presence of venous reflux obstruction; 4) Understand and agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients in the acute phase of DVT; 2) Patients with hypothyroidism; 3) Patients in whom the investigator judges that their intrinsic coagulation disorders would affect the outcome of this study; 4) Patients with severe CVI, such as those with venous ulcers, CEAP grade = 5, or patients with CEAP grade 5 without surgical indications; 5) Patients in the acute phase of inflammation; 6) Patients diagnosed with iliac vein compression by CTV or those requiring surgical treatment or endovascular recanalization for PTS; 7) Patients with medication-induced edema or those who have taken vasodilators within the past six months, including nitrates, receptor blockers, calcium channel blockers, angiotensin II receptor antagonists and so on; 8) Patients deemed unsuitable for participation in this clinical trial by the investigator, such as those with cardiac edema, renal edema, or hypoalbuminemic edema; 9) Patients who have received treatment to alleviate edema within the past two weeks; 10) Patients with an expected survival period of less than one year; 11) Pregnant or planning to become pregnant women; 12) Known allergies or intolerance to components of the investigational drug; 13) Patients who have participated in other drug clinical trials within the past three months or who intend to participate in other clinical trials during the course of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Circumference of Ankle; | — |
Secondary
| Measure | Time frame |
|---|---|
| Circumference of Shank;Villalta Score; | — |
Countries
China
Contacts
Public ContactLi Xiaoqiang
The Affiliated Hospital of Nanjing University Medical School, Nanjing Drum Tower Hospital
Outcome results
None listed