Efficacy and Tolerability of Venoactive Drugs in Patients With Chronic Venous Diseases C4a&b in Real Clinical Practice.
Chronic Venous Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04138576 ↗Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Servier Russia
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Subcutaneous Adipose Tissue Thickness Changes (mm) Between the Visit 3 and Baseline by Ultrasound Examination. |
2.5 | — |
| SECONDARY The Mean Changes VCSS for Pain (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale |
0.74 | — |
| SECONDARY The Mean Changes VCSS for Hyperpigmentation (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale |
0.49 | — |
| SECONDARY The Mean Changes VCSS for Inflammation (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale |
0.45 | — |
| SECONDARY Outcome Measure Title: The Mean Changes VCSS for Subcutaneous Tissue Induration (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale |
0.36 | — |
| SECONDARY The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). -Skin Tightening |
2.63 | — |
| SECONDARY The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Intensity of Burning Sensation |
2.40 | — |
| SECONDARY The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Skin Itching |
2.66 | — |
| SECONDARY The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Pain |
2.90 | — |
| SECONDARY The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Exudation |
0.48 | — |
| SECONDARY The Mean Changes of Global Index CIVIQ-14 Score (GIS) Between the Visit 3 and Baseline Evaluated |
22.4 | — |
| SECONDARY The Mean Lesion Area Changes Between the Visit 3 and Baseline Evaluated by Curvimetry Technique |
6.9 | — |
| SECONDARY The Mean Changes of the Skin Density Determined by Durometry Technique Between the Visit 3 and Baseline Evaluated. |
3.9 | — |
Summary
Eligibility Criteria
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 CEAP class C4
- No surgical intervention for CVD is planned by a doctor
Exclusion Criteria
- Chronic venous disease of СЕАР class C0-С3 or class С4-С6
- History of alcohol or drug abuse or use of narcotic drugs
- Peripheral artery disease
- 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
- Chronic kidney disease
- Decompensated diabetes mellitus
- Skin diseases of non-venous origin
- 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) History of surgical intervention (within the past 3 months) Patient cannot walk (regardless of the cause) Predictable poor adherence to treatment Participation of a 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 Patients with a contraindication to diosmin-containing agents, including Detralex Patient uses the topical treatments contraindicated in case of skin integrity violation.
Data sourced from ClinicalTrials.gov (NCT04138576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.