Overview
This multicenter, prospective, observational study aims to generate and analyze real-world data on the effectiveness and safety of Ruscus aculeatus L. treatment in patients with symptomatic chronic venous disease classified as CEAP C1-C6. Patients receiving Ruscus aculeatus L. as part of routine clinical practice will be followed for 90 days without any study-mandated intervention. Disease severity will be assessed using the revised Venous Clinical Severity Score (rVCSS), pain using the Visual Analog Scale (VAS), quality of life using the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20), treatment adherence using the Visual Analog Scale for adherence (VAS-U), and safety through the collection of adverse events during the observation period.
Description
Chronic venous disease (CVD) is a common condition associated with considerable morbidity and reduced quality of life. Ruscus aculeatus L. has been used as a venoactive agent for the symptomatic treatment of chronic venous disease; however, real-world clinical data on the use of Ruscus aculeatus L. alone remain limited.
This multicenter, prospective, observational study is designed to generate real-world evidence on the effectiveness, safety, treatment adherence, and quality of life associated with Ruscus aculeatus L. treatment in patients with symptomatic chronic venous disease classified as CEAP C1-C6. Patients who are prescribed Ruscus aculeatus L. as part of routine clinical practice will be followed for approximately 90 days without any study-specific intervention. Treatment decisions, diagnostic procedures, and patient management will remain entirely at the discretion of the treating physician.
Clinical outcomes will be evaluated using the revised Venous Clinical Severity Score (rVCSS), pain assessed by the Visual Analog Scale (VAS), quality of life assessed by the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20), treatment adherence assessed by the Visual Analog Scale for adherence (VAS-U), and safety assessed through the collection of adverse events during routine follow-up visits. Data will be collected during routine clinical visits at baseline, Day 30, and Day 90.
Eligibility
Inclusion Criteria:
- Adults aged 18 to 75 years.
- Patients prescribed Ruscus aculeatus L. as part of routine clinical practice, with the baseline visit performed within 7 days after treatment initiation.
- Symptomatic chronic venous disease classified as CEAP (2020) C1-C6.
- Willing and able to provide written informed consent and complete study as sessments.
Exclusion Criteria:
- Symptomatic patients classified as CEAP C0.
- Uncontrolled hypertension.
- Lower extremity dermatitis or ulcer related to peripheral arterial disease or diabetes.
- Neurological or orthopedic conditions limiting mobility or independent walking.
- Active systemic infection.
- Known malignancy or ongoing chemotherapy.
- Acute deep vein thrombosis or acute superficial vein thrombosis.
- Cognitive or physical conditions preventing participation in routine follow-up visits.
- Pregnant or breastfeeding women.
