Clinical trial NCT04138576: Efficacy and Tolerability of Venoactive Drugs in Patients With Chronic Venous Diseases C4a&b in Real Clinical Practice.
Official title: Evaluation of the Efficacy and Tolerability of Venoactive Drugs in Combination Therapy and Their Effect on the Overall Treatment Outcomes in Patients With Chronic Venous Diseases of CEAP Class C4a and C4b in Real Clinical Practice.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Venous Diseases
Lead sponsor: Servier Russia
Sponsor class: INDUSTRY
First posted: 2019-10-24
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with chronic venous diseases of CEAP class C4a and C4b

Brief summary: The study is aimed at evaluating the efficacy and tolerability of systemic pharmacotherapy as a part of combination treatment, and its influence on the overall treatment outcomes in patients with skin changes (CEAP class C4a and C4b).

Detailed description: Primary goal:

To study the efficacy of systemic pharmacotherapy as part of combination therapy and its impact on the:

* thickness of the skin-fat fold (ultrasound examination);
* change in the venous clinical severity score (VCSS);
* change in the CEAP clinical class of CVD;
* evolution of CVD symptoms characteristic for CEAP class C4 (sensations of skin tightening, burning, itching, pain, and exudation) using the Visual Analogue Scale (VAS).

Secondary goals:

1. To study the efficacy of systemic pharmacotherapy as part of combination therapy and its impact on the:

   * area of affected skin determined by curvimetry technique (only in selected centers that use this technique routinely) before and after the treatment in patients with skin changes of CEAP class C4a or C4b in real clinical practice;
   * skin density determined by durometry technique (only in selected centers that use this technique routinely).
2. To evaluate the changes in the quality of life using the CIVIQ-14 questionnaire (global index score \[GIS\]) .
3. To study the tolerability of systemic pharmacotherapy as part of combination therapy in patients with skin changes of CEAP class C4a or C4b.

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.

Primary outcomes:
measure: The Mean Subcutaneous Adipose Tissue Thickness Changes (mm) Between the Visit 3 and Baseline by Ultrasound Examination.
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). -Skin Tightening
timeFrame: 6 months
measure: The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Intensity of Burning Sensation
timeFrame: 6 months
measure: The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Skin Itching
timeFrame: 6 months
measure: The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Pain
timeFrame: 6 months
measure: The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Exudation
timeFrame: 6 months
measure: The Mean Changes of Global Index CIVIQ-14 Score (GIS) Between the Visit 3 and Baseline Evaluated
timeFrame: 6 months
measure: The Mean Lesion Area Changes Between the Visit 3 and Baseline Evaluated by Curvimetry Technique
timeFrame: 6 months
measure: The Mean Changes of the Skin Density Determined by Durometry Technique Between the Visit 3 and Baseline Evaluated.
timeFrame: 6 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Medical and Surgical Center. N.I. Pirogov
Study officials:
affiliation: Medical manager
name: Olga Linnik
role: STUDY_CHAIR
References:
citation: Bogachev V, Boldin B, Turkin P, Samenkov A, Dzhenina O. Micronized purified flavonoid fraction-based conservative treatment of chronic venous disease in a real-world setting. Future Cardiol. 2022 Sep;18(10):777-785. doi: 10.2217/fca-2022-0026. Epub 2022 Aug 25.