Status:
COMPLETED
Efficacy and Tolerability of Venoactive Drugs in Patients With Chronic Venous Diseases C4a&b in Real Clinical Practice.
Lead Sponsor:
Servier Russia
Conditions:
Chronic Venous Diseases
Eligibility:
All Genders
18+ years
Brief Summary
The study is aimed at evaluating the efficacy and tolerability of systemic pharmacotherapy as a part of combination treatment, and its influence on the overall treatment outcomes in patients with skin...
Detailed Description
Primary goal: To study the efficacy of systemic pharmacotherapy as part of combination therapy and its impact on the: * thickness of the skin-fat fold (ultrasound examination); * change in the venou...
Eligibility Criteria
Inclusion
- Age 18 years old or above
- Written informed consent
- Patient did not receive treatment with venoactive drugs within the past 4 -weeks prior to the inclusion in the study
- Diagnosis of chronic venous disease of CEAP class C4
- No surgical intervention for CVD is planned by a doctor
Exclusion
- Chronic venous disease of СЕАР class C0-С3 or class С4-С6
- History of alcohol or drug abuse or use of narcotic drugs
- Peripheral artery disease
- Lymphatic edema of the lower extremities
- Secondary varicose veins, angiodysplasia, or neoplasia
- Arterial disease (ankle-brachial index \<0.9)
- Infection within the past 6 weeks
- Any of the following concomitant diseases, which can affect the results:
- Connective tissue disease (including rheumatoid arthritis), arthritis
- Heart failure
- Chronic kidney disease
- Decompensated diabetes mellitus
- Skin diseases of non-venous origin
- Intermittent claudication (peripheral artery disease)
- Diseases of the bones or joints of the lower extremities
- Malignancy
- Treatment with drugs potentially causing leg edema (calcium channel blockers, hormonal drugs, NSAIDs, etc.) History of deep vein thrombosis (within the past year) History of superficial thrombophlebitis (within the past 3 months) History of surgical intervention (within the past 3 months) Patient cannot walk (regardless of the cause) Predictable poor adherence to treatment Participation of a patient in the intervention study within the previous 3 months For women: pregnancy or breastfeeding, the desire to become pregnant within at least 2 months after the study Patients with a contraindication to diosmin-containing agents, including Detralex Patient uses the topical treatments contraindicated in case of skin integrity violation.
Key Trial Info
Start Date :
December 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
381 Patients enrolled
Trial Details
Trial ID
NCT04138576
Start Date
December 25 2019
End Date
December 1 2020
Last Update
September 1 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Medical and Surgical Center. N.I. Pirogov
Moscow, Russia, 105203