Ecchymosis and Coldness in Patients With Varicose Vein

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

Detailed Description
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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.

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

Conditions
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Varicose Veins, Chronic Venous Insufficiency, Symptoms and General Pathology

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acceptance of inclusion aged between 18-75 years Exclusion Criteria: < 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Class 0<br>no visible or palpable varicose veins | |
| Class 1<br>telengiectasia ( thread veins, spider veins, broken veins) | |
| Class 2<br>varicose veins | |
| Class 3<br>edema | |
| Class 4<br>skin changes (pigmentation, eczema, lipodermatosclerosis, atrophie blanche) | |
| Class 5<br>healed venous ulcer | |
| Class 6<br>active venous ulcer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous Insufficiency Epidemiological and Economic Study- Symptom score evaluation | 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). | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of additional symptoms | Evaluation of additional symptoms (coldness and ecchymosis) | baseline | 
| CEAP (clinical, etiological, anatomical and pathological) clinical classification | CEAP clinical classification is an physical examination based scale to measure the severity of chronic venous disease: grade 0, no visible signs of venous disease; grade 1, telangiectasias or reticular veins; grade 2, varicose veins; grade 3, edema; grade 4, skin changes due to CVD; grade 5, skin changes with healed ulceration; and grade 6, skin changes with active ulceration. | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varicose veins, chronic venous disease, ecchymosis, symptoms