Ecchymosis and Coldness in Patients With Varicose Vein

NCT03384355 | Unknown

• 1 other identifier: Vasmol003
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Varicose Veins; Chronic Venous Insufficiency; Symptoms and General Pathology

Keywords

varicose veins; chronic venous disease; ecchymosis; symptoms

Outcome Measures

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).

  baseline

Secondary Outcomes (2)

• Evaluation of additional symptoms

  baseline

• CEAP (clinical, etiological, anatomical and pathological) clinical classification

  baseline

Study Arms (7)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• aged between 18-75 years

You may not qualify if:

• \< 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)

Sponsors & Collaborators

• Vascular and Molecular Cardiology Society: lead

Related 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. No abstract available.

  PMID: 27401694 RESULT

• 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.

  PMID: 27142148 RESULT

• 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.

  PMID: 25527517 RESULT

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

  RESULT

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

  PMID: 25700552 RESULT

• 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.

  PMID: 26443802 RESULT

• 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.

  PMID: 29660929 RESULT

MeSH Terms

Conditions

Varicose Veins; Pathological Conditions, Signs and Symptoms; Ecchymosis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Skin Manifestations; Signs and Symptoms

Study Officials

• Mehmet Ileri, MD

  Ankara City Hospital Bilkent

  STUDY CHAIR

Central Study Contacts

Ertan Yetkin, Professor

CONTACT

903243293900; ertanyetkin@vasmolcardiol.org

Selcuk Ozturk, MD

CONTACT

905535376613; selcukozturk85@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 27, 2017
• Study Start: January 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 27, 2017

Record last verified: 2017-12