- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03722836
Evaluation of the Efficacy and Tolerability of Detralex in Patients With Chronic Venous Edema in Real Clinical Practice (VAP-PRO-C3)
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Samara, Russian Federation, 443079
- Centr of flebology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4
Time Frame: 3 months
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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.
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3 months
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Changes in the Severity of Edema, as Assessed by the Method of Truncated Cones.
Time Frame: 3 months
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients' Quality of Life According to CIVIQ-14 - Visit 0 vs Visit4
Time Frame: 3 month
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yuriy Stoyko
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IC4-05682-055-RUS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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