Ecchymosis and Coldness in Patients With Varicose Vein

NCT ID: NCT03384355

Last Updated: 2017-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-31

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Varicose Veins Chronic Venous Insufficiency Symptoms and General Pathology

Keywords

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varicose veins chronic venous disease ecchymosis symptoms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Class 0

no visible or palpable varicose veins

No interventions assigned to this group

Class 1

telengiectasia ( thread veins, spider veins, broken veins)

No interventions assigned to this group

Class 2

varicose veins

No interventions assigned to this group

Class 3

edema

No interventions assigned to this group

Class 4

skin changes (pigmentation, eczema, lipodermatosclerosis, atrophie blanche)

No interventions assigned to this group

Class 5

healed venous ulcer

No interventions assigned to this group

Class 6

active venous ulcer

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vascular and Molecular Cardiology Society

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mehmet Ileri, MD

Role: STUDY_CHAIR

Ankara City Hospital Bilkent

Central Contacts

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Ertan Yetkin, Professor

Role: CONTACT

Phone: 903243293900

Email: [email protected]

Selcuk Ozturk, MD

Role: CONTACT

Phone: 905535376613

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 27401694 (View on PubMed)

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.

Reference Type RESULT
PMID: 27142148 (View on PubMed)

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.

Reference Type RESULT
PMID: 25527517 (View on PubMed)

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

Reference Type RESULT

Yetkin E. Complexity of venous symptoms. Phlebology. 2016 Mar;31(2):147. doi: 10.1177/0268355515574152. Epub 2015 Feb 19. No abstract available.

Reference Type RESULT
PMID: 25700552 (View on PubMed)

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.

Reference Type RESULT
PMID: 26443802 (View on PubMed)

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.

Reference Type RESULT
PMID: 29660929 (View on PubMed)

Other Identifiers

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Vasmol003

Identifier Type: -

Identifier Source: org_study_id