Ecchymosis and Coldness in Patients With Varicose Vein: Multicenter Study of Modified VEIN-Sym QoL Assessment
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 3,000
- Primary Endpoint
- Venous Insufficiency Epidemiological and Economic Study- Symptom score evaluation
Study Overview
Brief Summary
In this prospective, observational study, the investigators aim to investigate the symptoms of varicose vein patients.
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Evaluation of additional symptoms(baseline)
- CEAP (clinical, etiological, anatomical and pathological) clinical classification(baseline)