Chronic Venous Disease
Conditions
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.
Interventions
None listed
Sponsors
Servier Russia
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4 | 3 months | 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. |
| Changes in the Severity of Edema, as Assessed by the Method of Truncated Cones. | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' Quality of Life According to CIVIQ-14 - Visit 0 vs Visit4 | 3 month | 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. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With CVD of CEAP Class C3 the patients could receive any type of treatment for CVD | 708 |
| Total | 708 |
Baseline characteristics
| Characteristic | Patients With CVD of CEAP Class C3 | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 181 Participants | — |
| Age, Categorical Between 18 and 65 years | 527 Participants | — |
| Age, Continuous | 48.6 years STANDARD_DEVIATION 12.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Russia | 708 participants | — |
| Sex: Female, Male Female | 532 Participants | — |
| Sex: Female, Male Male | 176 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 708 |
| other Total, other adverse events | 0 / 708 |
| serious Total, serious adverse events | 0 / 708 |
Outcome results
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With CVD of CEAP Class C3 | Changes in the Severity of Edema, as Assessed by the Method of Truncated Cones. | 289 mL | Standard Deviation 234 |
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.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With CVD of CEAP Class C3 | Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4 | leg heaviness- Visit 0 | 53.8 mm | Standard Deviation 21.9 |
| Patients With CVD of CEAP Class C3 | Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4 | leg heaviness- Visit 4 | 15.6 mm | Standard Deviation 15.6 |
| Patients With CVD of CEAP Class C3 | Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4 | pain- Visit 0 | 42.4 mm | Standard Deviation 23.9 |
| Patients With CVD of CEAP Class C3 | Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4 | pain- Visit 4 | 11.2 mm | Standard Deviation 13.7 |
| Patients With CVD of CEAP Class C3 | Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4 | sensation of swelling - Visit 0 | 56.8 mm | Standard Deviation 24.4 |
| Patients With CVD of CEAP Class C3 | Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4 | sensation of swelling - Visit 4 | 13.8 mm | Standard Deviation 15.9 |
| Patients With CVD of CEAP Class C3 | Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4 | night cramps -Visit 0 | 24.6 mm | Standard Deviation 23.3 |
| Patients With CVD of CEAP Class C3 | Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4 | night cramps -Visit 4 | 5.8 mm | Standard Deviation 12 |
| Patients With CVD of CEAP Class C3 | Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4 | itching -Visit 0 | 14.6 mm | Standard Deviation 20.6 |
| Patients With CVD of CEAP Class C3 | Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4 | itching -Visit 4 | 4.3 mm | Standard Deviation 10.1 |
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.
Time frame: 3 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With CVD of CEAP Class C3 | Patients' Quality of Life According to CIVIQ-14 - Visit 0 vs Visit4 | psychological state scale -Visit 4 | 5.7 mean for index values | Standard Deviation 9 |
| Patients With CVD of CEAP Class C3 | Patients' Quality of Life According to CIVIQ-14 - Visit 0 vs Visit4 | pain scale - Visit 0 | 41.0 mean for index values | Standard Deviation 19.1 |
| Patients With CVD of CEAP Class C3 | Patients' Quality of Life According to CIVIQ-14 - Visit 0 vs Visit4 | pain scale - Visit 4 | 12.8 mean for index values | Standard Deviation 11.6 |
| Patients With CVD of CEAP Class C3 | Patients' Quality of Life According to CIVIQ-14 - Visit 0 vs Visit4 | scale of physical condition -Visit 0 | 31.6 mean for index values | Standard Deviation 23.8 |
| Patients With CVD of CEAP Class C3 | Patients' Quality of Life According to CIVIQ-14 - Visit 0 vs Visit4 | scale of physical condition -Visit 4 | 11.1 mean for index values | Standard Deviation 15.4 |
| Patients With CVD of CEAP Class C3 | Patients' Quality of Life According to CIVIQ-14 - Visit 0 vs Visit4 | psychological state scale -Visit 0 | 24.5 mean for index values | Standard Deviation 21.1 |
| Patients With CVD of CEAP Class C3 | Patients' Quality of Life According to CIVIQ-14 - Visit 0 vs Visit4 | Global index score - Visit 0 | 32.4 mean for index values | Standard Deviation 18.5 |
| Patients With CVD of CEAP Class C3 | Patients' Quality of Life According to CIVIQ-14 - Visit 0 vs Visit4 | Global index score - Visit 4 | 9.9 mean for index values | Standard Deviation 9.9 |