Trial Outcomes & Findings for Evaluation of the Efficacy and Tolerability of Detralex in Patients With Chronic Venous Edema in Real Clinical Practice (NCT NCT03722836)

Last Updated: 2023-01-13

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

708 participants

Primary outcome timeframe

3 months

Results posted on

2023-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With CVD of CEAP Class C3 the patients could receive any type of treatment for CVD
Overall Study STARTED	708
Overall Study COMPLETED	708
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With CVD of CEAP Class C3 n=708 Participants the patients could receive any type of treatment for CVD
Age, Categorical <=18 years	0 Participants n=708 Participants
Age, Categorical Between 18 and 65 years	527 Participants n=708 Participants
Age, Categorical >=65 years	181 Participants n=708 Participants
Age, Continuous	48.6 years STANDARD_DEVIATION 12.6 • n=708 Participants
Sex: Female, Male Female	532 Participants n=708 Participants
Sex: Female, Male Male	176 Participants n=708 Participants
Region of Enrollment Russia	708 participants n=708 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Patients With CVD of CEAP Class C3 n=708 Participants the patients could receive any type of treatment for CVD
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
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
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
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
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
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
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
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
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
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

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With CVD of CEAP Class C3 n=708 Participants the patients could receive any type of treatment for CVD
Changes in the Severity of Edema, as Assessed by the Method of Truncated Cones.	289 mL Standard Deviation 234

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With CVD of CEAP Class C3 n=708 Participants the patients could receive any type of treatment for CVD
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' 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' 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' 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' 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' 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' 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' 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

Adverse Events

Patients With CVD of CEAP Class C3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Manager-Olga Linnik

ServierRussia

Phone: 8-495-93707-00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place