Ecchymosis and Coldness in Patients With Varicose Vein (VEIN-COLD)

Vascular and Molecular Cardiology Society

Status: Unknown

Conditions: Symptoms and General Pathology; Chronic Venous Insufficiency; Varicose Veins

Study type: Observational

Funder types: Other

Identifiers

NCT03384355

Vasmol003

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

3,000 participants in 7 patient groups

Class 0

Description:

no visible or palpable varicose veins

Class 1

Description:

telengiectasia ( thread veins, spider veins, broken veins)

Class 2

Description:

varicose veins

Class 3

Description:

edema

Class 4

Description:

skin changes (pigmentation, eczema, lipodermatosclerosis, atrophie blanche)

Class 5

Description:

healed venous ulcer

Class 6

Description:

active venous ulcer