Clinical trial NCT03722836: Evaluation of the Efficacy and Tolerability of Detralex in Patients With Chronic Venous Edema in Real Clinical Practice
Official title: Multicenter Observational Program Evaluation of the Efficacy and Tolerability of Detralex Treatment in Patients With Chronic Venous Edema (CEAP Class С3) in Real Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Venous Disease
Lead sponsor: Servier Russia
Sponsor class: INDUSTRY
First posted: 2018-10-29
Enrollment: 708
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CVD

Brief summary: The VAP-PRO-C3 is a multicenter observational program, which is carried out in the frame of routine consultations and follow-up of patients. The program includes patients with chronic venous diseases (CVDs) of CEAP class C3. It is scheduled in Russia for 2018-2019. The program is expected to enroll 90 phlebologists from 60 cities of Russia. The planned number of patients is 900

Detailed description: The study is aimed at evaluating the efficacy and safety of systemic pharmacotherapy (Detralex) as a part of combination treatment, and its influence on the general outcomes of treatment of patients with chronic venous edema (CEAP class C3) in real clinical practice.

Each investigator is planned to include in the program 10 patients fulfilling the inclusion criteria. The treatment will be carried out in accordance to the routine clinical practice, instructions for the medical use of drugs, and a specific clinical situation. To assess changes in edema, the method of truncated cones and duplex ultrasound scanning (DUS) will be used.

Eligibility criteria: Inclusion Criteria:

* 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 class C3 (CEAP)
* Decision of an attending physician to prescribe Detralex.

Exclusion Criteria:

* Age below 18 years old
* Written informed consent is not obtained
* History of alcohol or drug abuse or use of narcotic drugs
* History of allergic reaction to diosmin or any other venoactive agent, or their intolerance
* History of allergic reaction to anesthetics and/or sclerosing agents
* Chronic venous disease of СЕАР class C0-С2 or class С4-С6
* 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
  * 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)
* Patient cannot walk (regardless of the cause)
* Obesity or body mass index \[BMI\] \>30 kg/m2 \[BMI = body mass (kg)/height (m)2\]
* Predictable poor adherence to treatment
* Participation of the 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
* Patient cannot attend a follow-up visit
* Patients with a contraindication to diosmin-containing agents, including Detralex

Primary outcomes:
measure: Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4
timeFrame: 3 months
measure: Changes in the Severity of Edema, as Assessed by the Method of Truncated Cones.
timeFrame: 3 months
Secondary outcomes:
measure: Patients' Quality of Life According to CIVIQ-14 - Visit 0 vs Visit4
timeFrame: 3 month
Other outcomes:
Locations:
city: Samara
country: Russian Federation
facility: Centr of flebology
Study officials:
name: Yuriy Stoyko
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bogachev VI, Boldin BV, Turkin PI, Samenkov AI; Study Group VAP-PRO-C3. [Comparative efficacy of various methods of treatment of chronic venous oedema in real clinical practice]. Angiol Sosud Khir. 2021;27(3):77-83. doi: 10.33529/ANGIO2021310. Russian.