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

Chronic Venous Disease Clinical Trial

— VAP-PRO-C3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03722836
• Other study ID #: IC4-05682-055-RUS
• Status: Completed
• Start date: December 6, 2018
• Est. completion date: June 20, 2019

Study information

• Verified date: April 2022
• Source: Servier Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 708
• Est. completion date: June 20, 2019
• Est. primary completion date: June 15, 2019
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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 ???? class C0-?2 or class ?4-?6
• 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

Related Conditions & MeSH terms

• Chronic Venous Disease

Locations

Country	Name	City	State
Russian Federation	Centr of flebology	Samara

Sponsors (1)

Lead Sponsor	Collaborator
Servier Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Patients' Quality of Life According to CIVIQ-14 - Visit 0 vs Visit4	Chronic Venous Insufficiency Questionnaire (CIVIQ-14) is a specific questionnaire for venous disease. It was used to describe the patients quality of life.; Questionnaire consists of 3 dimenions: 1. pain in ankles or legs 2. scale of physical condition 3.influence to psychological state It is a SELF-reported survey where each patient has to circle the number (from 1 to 5): of which 1 means NO signs or symptons (the best result) and 5 stands for the worst state CIVIQ 14 consists of 14 questions, each question has a maximum score of 5 points. So 70 points indicates maximum reduced QoL, and 14 - best state of QoL.; In order to compare the mean scores between dimensions, absolute scores were converted into an index. For each dimension, we obtained a result ranging from 0 to 100. Interpretation: the highest figure can be allocated to the lowest response option and vice versa.	3 month