CClinicalTrials.gg
Status unknownNCT03384355VEIN-COLDUpdated Dec 27, 2017

Ecchymosis and Coldness in Patients With Varicose Vein

An observational study in Varicose Veins, Chronic Venous Insufficiency and Symptoms and General Pathology, sponsored by Vascular and Molecular Cardiology Society. Status unknown. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-27.

Sponsored by Vascular and Molecular Cardiology Society · Observational

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

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

Keywords

  • varicose veins
  • chronic venous disease
  • ecchymosis
  • symptoms
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

Inclusion criteria

  • acceptance of inclusion
  • aged between 18-75 years

Exclusion criteria

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)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: baseline

Secondary outcomes

  1. Evaluation of additional symptoms

    Evaluation of additional symptoms (coldness and ecchymosis)

    Time frame: baseline

  2. 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.

    Time frame: baseline

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 27401694 ↗
  • 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. PubMed 27142148 ↗
  • 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. PubMed 25527517 ↗
  • 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. No abstract available. PubMed 25700552 ↗
  • 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. PubMed 26443802 ↗
  • 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. PubMed 29660929 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03384355
Lead sponsor
Vascular and Molecular Cardiology Society
Responsible party
Sponsor
First posted
Dec 27, 2017
Start date
Jan 2018 (estimated)
Primary completion
Dec 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Dec 27, 2017

Study contacts

Ertan Yetkin, Professor
Contact
ertanyetkin@vasmolcardiol.org
903243293900
Selcuk Ozturk, MD
Contact
selcukozturk85@hotmail.com
905535376613
Mehmet Ileri, MD
study chair · Ankara City Hospital Bilkent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion