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Ecchymosis and Coldness in Patients With Varicose Vein

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Status
Patrocinadores
Vascular and Molecular Cardiology Society

Palavras-chave

Resumo

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

Descrição

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.

datas

Última verificação: 11/30/2017
Enviado pela primeira vez: 12/17/2017
Inscrição estimada enviada: 12/23/2017
Postado pela primeira vez: 12/26/2017
Última atualização enviada: 12/23/2017
Última atualização postada: 12/26/2017
Data real de início do estudo: 12/31/2017
Data Estimada de Conclusão Primária: 11/30/2018
Data Estimada de Conclusão do Estudo: 11/30/2018

Condição ou doença

Varicose Veins
Chronic Venous Insufficiency
Symptoms and General Pathology

Fase

-

Grupos de Armas

BraçoIntervenção / tratamento
Class 0
no visible or palpable varicose veins
Class 1
telengiectasia ( thread veins, spider veins, broken veins)
Class 2
varicose veins
Class 3
edema
Class 4
skin changes (pigmentation, eczema, lipodermatosclerosis, atrophie blanche)
Class 5
healed venous ulcer
Class 6
active venous ulcer

Critério de eleição

Idades qualificadas para estudar 18 Years Para 18 Years
Sexos elegíveis para estudoAll
Método de amostragemProbability Sample
Aceita Voluntários Saudáveissim
Critério

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)

Resultado

Medidas de Resultado Primário

1. Venous Insufficiency Epidemiological and Economic Study- Symptom score evaluation [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).

Medidas de Resultado Secundário

1. Evaluation of additional symptoms [baseline]

Evaluation of additional symptoms (coldness and ecchymosis)

2. CEAP (clinical, etiological, anatomical and pathological) clinical classification [baseline]

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.

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