Ecchymosis and Coldness in Patients With Varicose Vein (VEIN-COLD)
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|ClinicalTrials.gov Identifier: NCT03384355|
Recruitment Status : Not yet recruiting
First Posted : December 27, 2017
Last Update Posted : December 27, 2017
|Condition or disease|
|Varicose Veins Chronic Venous Insufficiency Symptoms and General Pathology|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||3000 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Ecchymosis and Coldness in Patients With Varicose Vein: Multicenter Study of Modified VEIN-Sym QoL Assessment|
|Estimated Study Start Date :||January 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
no visible or palpable varicose veins
telengiectasia ( thread veins, spider veins, broken veins)
skin changes (pigmentation, eczema, lipodermatosclerosis, atrophie blanche)
healed venous ulcer
active venous ulcer
- Venous Insufficiency Epidemiological and Economic Study- Symptom score evaluation [ Time Frame: 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).
- Evaluation of additional symptoms [ Time Frame: baseline ]Evaluation of additional symptoms (coldness and ecchymosis)
- CEAP (clinical, etiological, anatomical and pathological) clinical classification [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384355
|Contact: Ertan Yetkin, Professorfirstname.lastname@example.org|
|Contact: Selcuk Ozturk, MDemail@example.com|
|Study Chair:||Mehmet Ileri, MD||Ankara City Hospital Bilkent|