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

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ClinicalTrials.gov Identifier: NCT03384355
Recruitment Status : Not yet recruiting
First Posted : December 27, 2017
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Vascular and Molecular Cardiology Society

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

Condition or disease
Varicose Veins Chronic Venous Insufficiency Symptoms and General Pathology

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Ecchymosis and Coldness in Patients With Varicose Vein: Multicenter Study of Modified VEIN-Sym QoL Assessment
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Group/Cohort
Class 0
no visible or palpable varicose veins
Class 1
telengiectasia ( thread veins, spider veins, broken veins)
Class 2
varicose veins
Class 3
edema
Class 4
skin changes (pigmentation, eczema, lipodermatosclerosis, atrophie blanche)
Class 5
healed venous ulcer
Class 6
active venous ulcer



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Evaluation of additional symptoms [ Time Frame: baseline ]
    Evaluation of additional symptoms (coldness and ecchymosis)

  2. CEAP (clinical, etiological, anatomical and pathological) clinical classification [ Time Frame: baseline ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients admitting to cardiology and/or cardiovascular surgery outpatient clinics and do not match the exclusion criteria
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384355


Contacts
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Contact: Ertan Yetkin, Professor 903243293900 ertanyetkin@vasmolcardiol.org
Contact: Selcuk Ozturk, MD 905535376613 selcukozturk85@hotmail.com

Sponsors and Collaborators
Vascular and Molecular Cardiology Society
Investigators
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Study Chair: Mehmet Ileri, MD Ankara City Hospital Bilkent

Additional Information:

Publications of Results:
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Responsible Party: Vascular and Molecular Cardiology Society
ClinicalTrials.gov Identifier: NCT03384355     History of Changes
Other Study ID Numbers: Vasmol003
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vascular and Molecular Cardiology Society:
varicose veins
chronic venous disease
ecchymosis
symptoms
Additional relevant MeSH terms:
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Venous Insufficiency
Varicose Veins
Ecchymosis
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms