Evaluation of the Efficacy and Tolerability of Detralex in Patients With Chronic Venous Edema in Real Clinical Practice

NCT03722836 | Completed Results

• 1 other identifier: IC4-05682-055-RUS
• Study Type: observational
• Target: 708
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Venous Disease

Outcome Measures

Primary Outcomes (2)

• Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4

  Visual Analog Scale (VAS) was used in the VAP-PRO-C3 study in to discribe 5 criterions: 1.leg heaviness, 2.pain, 3. sensation of swelling, 4. night cramps 5. itching reduced from Description of the technique: It is a continuous scale in the form of a horizontal line 100 mm long with two extreme points located on it: "no symptom" and "the strongest symptom you can imagine." The patient is asked to place a line perpendicularly crossing the visual analogue scale at the point that corresponds to his symptom intensity. The ruler measures the distance (mm) between "no symptom" and "the strongest symptom you can imagine," providing a score range from 0 to 100. A higher score indicates a greater intensity of symptom.

  3 months

• Changes in the Severity of Edema, as Assessed by the Method of Truncated Cones.

  To assess changes in edema, the method of truncated cones and duplex ultrasound scanning (DUS) will be used. The method is based on the assumption that the shape of the lower extremity approaches the shape of several truncated cones connected by bases that coincide in area. The volume of the cone is calculated by measuring the circumference of the upper (C) and lower (c) cones and the height (h) between them. For calculating the volume of each cone, the following formula is used: V = (p / 12p) ² h (C² + Cc + c²), The volume of the lower limb is determined by summing the volumes of all the cones. The smaller the height of the segments, the more accurate the result.

  3 months

Secondary Outcomes (1)

• Patients' Quality of Life According to CIVIQ-14 - Visit 0 vs Visit4

  3 month

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with CVD

You may qualify if:

• Age 18 years old or above
• Written informed consent
• Diagnosis of chronic venous disease of class C3 (CEAP)
• Decision of an attending physician to prescribe Detralex.

You may not qualify if:

• 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

Sponsors & Collaborators

• Servier Russia: lead

Study Sites (1)

Centr of flebology

Samara, 443079, Russia

Location

Related Publications (1)

• 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.

  PMID: 34528591 DERIVED

Results Point of Contact

• Title: Medical Manager-Olga Linnik
• Organization: ServierRussia

olga.linnik@servier.com

8-495-93707-00

Study Officials

• Yuriy Stoyko

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 29, 2018
• Study Start: December 6, 2018
• Primary Completion: June 15, 2019
• Study Completion: June 20, 2019
• Last Updated: January 13, 2023
• Results First Posted: January 13, 2023

Record last verified: 2022-04

Locations

RU (1)