Outcomes of Different Treatment Options in Chronic Venous Disease

Официальное название

An Observational, Prospective Study to Assess the Outcomes of Different Treatment Options in Patients With Chronic Venous Disease in Belgium

Обзор

This study aims to describe conservative and invasive treatments for patients with chronic venous disease (CVD) in Belgium, and their association with clinical and patient-reported outcomes during a follow-up of 24 months.

Подробное описание

This study is an observational, prospective, multicentre study to assess the effectiveness of conservative and invasive treatments in patients with CVD in Belgium. The inclusion period of the study will last 6 months. Patients will be followed until 2 years after inclusion into the study.

During the inclusion period, after confirmation of eligibility, patients with CVD diagnosed by the General Practitioner (GP) and requiring a treatment will be invited to participate in the study. About 140 GPs across Belgium will be included in the study. During the first visit, a treatment strategy will be proposed to the patient by the GP. The treatment can be conservative or invasive, depending on the severity of the disease. Patients awaiting invasive treatment may receive conservative treatment to alleviate symptoms. The choice of treatment modality is left to the discretion of the treating physician, in agreement with the patient and according to local policies. As this is an observational study, there will be no interference in the choice of treatment, and no restrictions will be imposed.

Вмешательства

• Процедура Radiofrequency ablation using Closure fast
  Thermal ablation technique
• Процедура Aethoxysclerol
  sclero-or foamsclerose
• Препарат Daflon
  Venoactive drugs
• Устройство Compression stocking
  Compression

Первичные конечные точки

• Change in Chronic Venous Insufficiency QOL questionnaire- 20 (CIVIQ-20) score [Срок оценки: baseline to 12 weeks]

Вторичные конечные точки (7)

• Intervention as secondary/add-on treatment [Срок оценки: month 24]
• The change in the Chronic Venous Insufficiency QOL questionnaire-20 score (CIVIQ-20) [Срок оценки: through study completion, an average of 2 years]
• The change in the clinical part of the Clinical, Etiological, Anatomical and Pathophysiological classification (CEAP classification) [Срок оценки: through study completion, an average of 2 years]
• The change in the revised Venous Clinical Severity Score (rVCSS) [Срок оценки: through study completion, an average of 2 years]
• The change in the symptoms, recorded with a questionnaire [Срок оценки: through study completion, an average of 2 years]
• The change in satisfaction score [Срок оценки: through study completion, an average of 2 years]
• Adverse Events (AEs). [Срок оценки: month 24]

Критерии участия

Критерии включения

\* Patient visiting a GP with complaints related to CVD,

• Patient receiving the diagnosis of CVD from the GP during the V0, according to international guidelines and made on a clinical basis,
• Patient requiring and agreeing to receive conservative or invasive treatment,
• French or Dutch speaking patient,
• Patient signed informed consent and agrees to take part in the study and follow-up.

Критерии исключения

• Patient with coagulation disorders such as thrombophilia and/or taking anticoagulation drugs,
• Pregnant or breastfeeding patient,
• Patient with severe Peripheral Arterial Occlusive Disease (POAD), with Ankle Brachial Index (ABI) < 0.8,
• Patient with malignancy,
• Patient with neurological disorder or dementia,
• Patients taking regular treatment for CVD 3 months prior to inclusion (except painkillers or anti-inflammatory drugs if taken for reasons other than CVD),
• Patient in any other clinical study for any pharmaceutical product within 4 weeks preceding study inclusion,
• Patient with any comorbidity or situation preventing a follow-up of 2 years.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06318988 · S67030

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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