Ecchymosis and Coldness in Patients With Varicose Vein

Varicose Veins Clinical Trial

— VEIN-COLD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03384355
• Other study ID #: Vasmol003
• Status: Not yet recruiting
• Phase: N/A
• First received: December 18, 2017
• Last updated: December 24, 2017
• Start date: January 2018
• Est. completion date: December 2018

Study information

• Verified date: December 2017
• Source: Vascular and Molecular Cardiology Society
• Contact: Ertan Yetkin, Professor
• Phone: 903243293900
• Email: ertanyetkin[@]vasmolcardiol.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Ecchymosis
• Symptoms and General Pathology
• Varicose Veins
• Venous Insufficiency

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vascular and Molecular Cardiology Society

References & Publications (7)

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. — View Citation

Yetkin E, Ileri M, Waltenberger, J. Ecchymosis: A novel sign in patients with varicose vein. Clin Hemor and Microcirc. 2017. doi: 10.3233/CH-170320.

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. — View Citation

Yetkin E, Öztürk S and Ileri M. Varicose Vein And Ecchymosis: A Case Report. International Archives of Medicine. 2017; 10.

Yetkin E. Complexity of venous symptoms. Phlebology. 2016 Mar;31(2):147. doi: 10.1177/0268355515574152. Epub 2015 Feb 19. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous Insufficiency Epidemiological and Economic Study- Symptom score evaluation	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).	baseline
Secondary	Evaluation of additional symptoms	Evaluation of additional symptoms (coldness and ecchymosis)	baseline
Secondary	CEAP (clinical, etiological, anatomical and pathological) clinical classification	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.	baseline