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临床试验/NCT03384355
NCT03384355Unknown不适用

Ecchymosis and Coldness in Patients With Varicose Vein: Multicenter Study of Modified VEIN-Sym QoL Assessment

Vascular and Molecular Cardiology Society0 个研究点目标入组 3,000 人开始时间: 2018年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3,000
主要终点
Venous Insufficiency Epidemiological and Economic Study- Symptom score evaluation

研究概览

简要总结

In this prospective, observational study, the investigators aim to investigate the symptoms of varicose vein patients.

详细描述

Chronic venous disease is very common in all over the world and affects both the mortality and morbidity depending on the effected vascular territory. It is often overlooked by healthcare professionals due to the underestimation of the prevalence and impact of the disease. It represents a spectrum of conditions varying from simple telangiectasia or reticular veins to skin fibrosis and venous ulceration. The main clinical characteristics are dilated veins, edema, leg pain, and cutaneous alterations in the legs. Varicose veins are dilating superficial veins, which become more tortuous and enlarged, continuously.

Chronic venous disease affects the life quality of patients suffering from the disease, which can be measured with quality-of-life reports. Venous Insufficiency Epidemiological and Economic Study-Quality of Life/Symptoms (VEINES-QoL/Sym) questionnaire is a patient based, designed for self-completion instrument to measure both the symptom severity and quality of life. VEINES-QOL measures life quality and VEINES-Sym provides an overall estimate of CVD symptom frequency. From the practitioners daily knowledge of patients with varicose veins, there is a significant proportion of varicose vein patients also suffering from symptoms such as coldness and ecchymosis. In this context, the investigators aim to investigate the symptoms of participants with varicose vein using the VEINES-Sym questionnaire.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •acceptance of inclusion
  • •aged between 18-75 years

排除标准

  • •< 18 year old
  • •> 75 year old
  • •malignancy
  • •active infection
  • •hematological disease (severe anemia, leukemia, polistemia vera, sickle cell disease)
  • •collagen tissue disease
  • •severe decompensated heart failure (ejection fraction < 40%)
  • •cor pulmonale
  • •rheumatoid arthritis
  • •degenerative arthritis
  • •history of lower extremity orthopedic surgery
  • •lombar disk hernia
  • •history of coronary artery by-pass surgery
  • •severe psychiatric and neurological disease (parkinson disease, schizophrenia, bipolar disease, alzheimer disease, etc.)
  • •peripheral arterial disease ( history of interventional procedure, claudication, active ischemic complaints)

结局指标

主要结局

Venous Insufficiency Epidemiological and Economic Study- Symptom score evaluation

时间窗: baseline

Venous Insufficiency Epidemiological and Economic Study-Quality of Life/Symptoms (VEINES-QoL/Sym) questionnaire is a patient based, designed for self-completion instrument to measure both the symptom severity and quality of life. VEINES-QOL measures life quality and VEINES-Sym provides an overall estimate of CVD symptom frequency. Lower VEINES-Sym scores indicate more severe symptoms and higher VEINES-QoL/Sym scores indicate better QoL.VEINES-Sym consists of ten items including nine venous symptoms (heavy legs, aching legs, swelling, night cramps, heat/burning sensation, restless legs, throbbing, itching and tingling sensation) in five different frequencies (1=everyday, 2= several times a week, 3= about once a week, 4= less than once a week, 5= never) and leg pain rated on a six-point scale of intensity (1 = very severe, 2= severe, 3 =moderate, 4 = mild, 5 =very mild, 6= none).

次要结局

  • Evaluation of additional symptoms(baseline)
  • CEAP (clinical, etiological, anatomical and pathological) clinical classification(baseline)

研究者

发起方
Vascular and Molecular Cardiology Society
申办方类型
Other
责任方
Sponsor

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