An Observational, Prospective Study to Assess the Outcomes of Different Treatment Options in Patients With Chronic Venous Disease in Belgium
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000
- 主要终点
- Change in Chronic Venous Insufficiency QOL questionnaire- 20 (CIVIQ-20) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* 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.
排除标准
- •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.
研究组 & 干预措施
conservative
compression therapy, and oral or topical venoactive drugs
干预措施: Daflon (Drug)
conservative
compression therapy, and oral or topical venoactive drugs
干预措施: Compression stocking (Device)
invasive
sclerotherapy, foamsclerotherapy, open surgery, endovenous thermal ablation
干预措施: Radiofrequency ablation using Closure fast (Procedure)
invasive
sclerotherapy, foamsclerotherapy, open surgery, endovenous thermal ablation
干预措施: Aethoxysclerol (Procedure)
结局指标
主要结局
Change in Chronic Venous Insufficiency QOL questionnaire- 20 (CIVIQ-20) score
时间窗: baseline to 12 weeks
Chronic Venous Insufficiency QOL questionnaire-20 score, min 20 max 100, higher means worse outcome
次要结局
- Intervention as secondary/add-on treatment(month 24)
- The change in the revised Venous Clinical Severity Score (rVCSS)(through study completion, an average of 2 years)
- The change in satisfaction score(through study completion, an average of 2 years)
- The change in the Chronic Venous Insufficiency QOL questionnaire-20 score (CIVIQ-20)(through study completion, an average of 2 years)
- The change in the clinical part of the Clinical, Etiological, Anatomical and Pathophysiological classification (CEAP classification)(through study completion, an average of 2 years)
- The change in the symptoms, recorded with a questionnaire(through study completion, an average of 2 years)
- Adverse Events (AEs).(month 24)