Clinical trial NCT03384355: Ecchymosis and Coldness in Patients With Varicose Vein
Official title: Ecchymosis and Coldness in Patients With Varicose Vein: Multicenter Study of Modified VEIN-Sym QoL Assessment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Varicose Veins
Chronic Venous Insufficiency
Symptoms and General Pathology
Keywords: varicose veins
chronic venous disease
ecchymosis
symptoms
Lead sponsor: Vascular and Molecular Cardiology Society
Sponsor class: OTHER
First posted: 2017-12-27
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients admitting to cardiology and/or cardiovascular surgery outpatient clinics and do not match the exclusion criteria

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Venous Insufficiency Epidemiological and Economic Study- Symptom score evaluation
timeFrame: baseline
Secondary outcomes:
measure: Evaluation of additional symptoms
timeFrame: baseline
measure: CEAP (clinical, etiological, anatomical and pathological) clinical classification
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Mehmet Ileri, MD
role: STUDY_CHAIR
References:
citation: Ozturk S, Yetkin E. Identifying symptoms in chronic venous diseases. Eur J Obstet Gynecol Reprod Biol. 2016 Aug;203:331. doi: 10.1016/j.ejogrb.2016.04.011. Epub 2016 Jun 23. No abstract available.
citation: Yetkin E, Ileri M. Dilating venous disease: Pathophysiology and a systematic aspect to different vascular territories. Med Hypotheses. 2016 Jun;91:73-76. doi: 10.1016/j.mehy.2016.04.016. Epub 2016 Apr 11.
citation: Yetkin E. Hemorrhoid, internal iliac vein reflux and peripheral varicose vein: Affecting each other or affected vessels? Phlebology. 2015 Mar;30(2):145. doi: 10.1177/0268355514565196. Epub 2014 Dec 19. No abstract available.
citation: Yetkin E, Öztürk S and Ileri M. Varicose Vein And Ecchymosis: A Case Report. International Archives of Medicine. 2017; 10.
citation: Yetkin E. Complexity of venous symptoms. Phlebology. 2016 Mar;31(2):147. doi: 10.1177/0268355515574152. Epub 2015 Feb 19. No abstract available.
citation: Yetkin E. Images in Vascular Medicine. A new or overlooked finding of varicose veins: Ecchymosis. Vasc Med. 2016 Feb;21(1):75-6. doi: 10.1177/1358863X15607654. Epub 2015 Oct 5. No abstract available.
citation: Yetkin E, Ileri M, Waltenberger J. Ecchymosis: A novel sign in patients with varicose veins. Clin Hemorheol Microcirc. 2018;68(4):413-419. doi: 10.3233/CH-170320.