An observational study in Chronic Venous Disease, sponsored by Servier Russia. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2023-01-13.
Sponsored by Servier Russia · Observational
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
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.
Servier Russia is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with CVD
Exclusion Criteria:
Any of the following concomitant diseases, which can affect the results:
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
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
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
| Milestone | Patients With CVD of CEAP Class C3 |
|---|---|
| Started | 708 |
| Completed | 708 |
| Not completed | 0 |
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.
| mm | Patients With CVD of CEAP Class C3 |
|---|---|
| leg heaviness- Visit 0 | 53.8 ± 21.9 |
| leg heaviness- Visit 4 | 15.6 ± 15.6 |
| pain- Visit 0 | 42.4 ± 23.9 |
| pain- Visit 4 | 11.2 ± 13.7 |
| sensation of swelling - Visit 0 | 56.8 ± 24.4 |
| sensation of swelling - Visit 4 | 13.8 ± 15.9 |
| night cramps -Visit 0 | 24.6 ± 23.3 |
| night cramps -Visit 4 | 5.8 ± 12 |
| itching -Visit 0 | 14.6 ± 20.6 |
| itching -Visit 4 | 4.3 ± 10.1 |
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.
| mL | Patients With CVD of CEAP Class C3 |
|---|---|
| Changes in the Severity of Edema, as Assessed by the Method of Truncated Cones. | 289 ± 234 |
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.
| mean for index values | Patients With CVD of CEAP Class C3 |
|---|---|
| pain scale - Visit 0 | 41.0 ± 19.1 |
| pain scale - Visit 4 | 12.8 ± 11.6 |
| scale of physical condition -Visit 0 | 31.6 ± 23.8 |
| scale of physical condition -Visit 4 | 11.1 ± 15.4 |
| psychological state scale -Visit 0 | 24.5 ± 21.1 |
| psychological state scale -Visit 4 | 5.7 ± 9 |
| Global index score - Visit 0 | 32.4 ± 18.5 |
| Global index score - Visit 4 | 9.9 ± 9.9 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients With CVD of CEAP Class C3 | 0/708 (0%) | 0/708 (0%) | 0/708 (0%) |
| Age, Categorical(Participants) | Patients With CVD of CEAP Class C3 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 527 |
| >=65 years | 181 |
| Age, Continuous(years) | Patients With CVD of CEAP Class C3 |
|---|---|
| Mean | 48.6 ± 12.6 |
| Sex: Female, Male(Participants) | Patients With CVD of CEAP Class C3 |
|---|---|
| Female | 532 |
| Male | 176 |
| Race and Ethnicity Not Collected(Participants) | Patients With CVD of CEAP Class C3 |
|---|
| Region of Enrollment(participants) | Patients With CVD of CEAP Class C3 |
|---|---|
| Russia | 708 |
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Servier Russia