Varicose VeinsVEIN-COLDNCT03384355
Ecchymosis and Coldness in Patients With Varicose Vein
An observational study of Varicose Veins and Chronic Venous Insufficiency, run by Vascular and Molecular Cardiology Society.
Trial summary
In this prospective, observational study, the investigators aim to investigate the symptoms of varicose vein patients. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicose Veins, Chronic Venous Insufficiency, Symptoms and General Pathology
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Dec 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients admitting to cardiology and/or cardiovascular surgery outpatient clinics and do not match the exclusion criteria
Who may be able to join
- acceptance of inclusion
- aged between 18-75 years
Who cannot join
- < 18 year old
- > 75 year old
- malignancy
- active infection
- hematological disease (severe anemia, leukemia, polistemia vera, sickle cell disease)
- collagen tissue disease
Show all 15Show fewer
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
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.
- Keywords
- varicose veins, chronic venous disease, ecchymosis, symptoms
- Medical subject headings
- Varicose Veins, Pathological Conditions, Signs and Symptoms, Ecchymosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline
Secondary outcomes (2)
Evaluation of additional symptoms
Evaluation of additional symptoms (coldness and ecchymosis)
Measured: baseline
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study startJan 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Vascular and Molecular Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehmet Ileri, MD, Study chair, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384355
- Sponsor's protocol ID
- Vasmol003
- Acronym
- VEIN-COLD
- Status last verified
- Dec 2017
- First submitted
- 18 Dec 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 27401694Yetkin 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 27142148Yetkin 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 25527517Yetkin 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 25700552Yetkin 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 26443802Yetkin 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ecchymosis and Coldness in Patients With Varicose Vein: Multicenter Study of Modified VEIN-Sym QoL Assessment
- ClinicalTrials.gov ID
- NCT03384355
- Acronym / sponsor ID
- VEIN-COLD / Vasmol003
- Keywords
- varicose veins, chronic venous disease, ecchymosis, symptoms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Vascular and Molecular Cardiology SocietyUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective, observational study, the investigators aim to investigate the symptoms of varicose vein patients.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitting to cardiology and/or cardiovascular surgery outpatient clinics and do not match the exclusion criteria
Key inclusion criteria (2 listed)
- acceptance of inclusion
- aged between 18-75 years
Key exclusion criteria (15 listed)
- < 18 year old
- > 75 year old
- malignancy
- active infection
- hematological disease (severe anemia, leukemia, polistemia vera, sickle cell disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
Evaluation of additional symptoms
Time frame: baseline
CEAP (clinical, etiological, anatomical and pathological) clinical classification
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- Results publication: PubMed 27401694Ozturk 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.
- Results publication: PubMed 27142148Yetkin 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.
- Results publication: PubMed 25527517Yetkin 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.
- Results publicationYetkin E, Öztürk S and Ileri M. Varicose Vein And Ecchymosis: A Case Report. International Archives of Medicine. 2017; 10.
- Results publication: PubMed 25700552Yetkin E. Complexity of venous symptoms. Phlebology. 2016 Mar;31(2):147. doi: 10.1177/0268355515574152. Epub 2015 Feb 19. No abstract available.
- Results publication: PubMed 26443802Yetkin 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.
- Results publication: PubMed 29660929Yetkin 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.
- Individual participant dataSharing planned: Undecided
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Varicose Veins
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Ileri, MD study chair
Ankara City Hospital Bilkent
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins and Chronic Venous Insufficiency, run by Vascular and Molecular Cardiology Society.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ertan Yetkin, Professor (903243293900, ertanyetkin@vasmolcardiol.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous Insufficiency Epidemiological and Economic Study- Symptom score evaluation (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03384355, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2017.