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

December 24, 2017 updated by: Vascular and Molecular Cardiology Society

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

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

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients admitting to cardiology and/or cardiovascular surgery outpatient clinics and do not match the exclusion criteria

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of additional symptoms
Time Frame: baseline
Evaluation of additional symptoms (coldness and ecchymosis)
baseline
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vascular and Molecular Cardiology Society

Investigators

  • Study Chair: Mehmet Ileri, MD, Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

December 24, 2017

First Posted (ACTUAL)

December 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 27, 2017

Last Update Submitted That Met QC Criteria

December 24, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vasmol003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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