Skip to content

Ecchymosis and Coldness in Patients With Varicose Vein

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03384355
Acronym
VEIN-COLD
Enrollment
3000
Registered
2017-12-27
Start date
2018-01-31
Completion date
2018-12-31
Last updated
2017-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Venous Insufficiency, Symptoms and General Pathology, Varicose Veins

Keywords

varicose veins, chronic venous disease, ecchymosis, symptoms

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.

Interventions

None listed

Sponsors

Vascular and Molecular Cardiology Society
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Venous Insufficiency Epidemiological and Economic Study- Symptom score evaluationbaselineVenous 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

MeasureTime frameDescription
Evaluation of additional symptomsbaselineEvaluation of additional symptoms (coldness and ecchymosis)
CEAP (clinical, etiological, anatomical and pathological) clinical classificationbaselineCEAP 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.

Contacts

Primary ContactErtan Yetkin, Professor
ertanyetkin@vasmolcardiol.org903243293900
Backup ContactSelcuk Ozturk, MD
selcukozturk85@hotmail.com905535376613

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026