Venous InsufficiencyNCT06369207
Investigation of the Transmission Pathways of Reflux in Patients With Chronic Venous Insufficiency
An observational study of Venous Insufficiency, run by Golestan University of Medical sciences at 1 site in Iran.
Trial summary
Chronic venous insufficiency (CVI) is one of the most common medical problems in adults that occurs secondary to the reflux of blood through incompetent valves of lower extremity veins. The most common involved valve is the valve located at the saphenofemoral junction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Insufficiency
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 12 Sep 2023to 15 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All included participants are visited the day before surgery and venous mapping is performed for the patient by the vascular surgeon. The reflux pathway is marked on the skin and information regarding the anatomic characteristics of the reflux are recorded.
Who may be able to join
- Age>18.
- Chronic Venous Insufficiency with a clinical grade of 3 (varicosity) or more.
- Documentation of saphenofemoral junction insufficiency on Doppler ultrasound performed by a radiologist.
- Patient consent.
Who cannot join
- History of DVT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Reflux Transmission Pathways in Chronic Venous Insufficiency Patients Secondary to Saphenofemoral Reflux, Presenting to Vascular Surgery Clinics of Golestan Province From 2022 Till 2023
Chronic venous insufficiency (CVI) is one of the most common medical problems in adults that occurs secondary to the reflux of blood through incompetent valves of lower extremity veins. The most common involved valve is the valve located at the saphenofemoral junction. Although the pathway of reflux transmission is not the same in all patients, the removal or ablation of the greater saphenous vein (GSV) is considered a standard treatment in these patients. However, in patients whose reflux is transmitted to branches other than GSV, this treatment leads to the unnecessary destruction of a competent segment of GSV in addition to remaining at least some segments of incompetent veins. So, in this study, the investigators intend to investigate the different pathways of reflux transmission in chronic venous insufficiency patients who are candidates for GSV ablation/stripping because of saphenofemoral junction insufficiency. This cross-sectional study will be conducted with a descriptive-analytical approach. .
Read the detailed description
Chronic venous insufficiency is one of the most common medical diseases in adults, which severely affects the quality of life of affected patients. What causes symptoms in this disease is the reflux of blood through incompetent valves located in the lower extremity veins. The most common cause is saphenofemoral valve insufficiency.
Although the pathway of reflux transmission is not the same in all patients, the removal of the greater saphenous vein (GSV) is considered a standard treatment according to the guidelines. This treatment leads to unnecessary destruction of the great saphenous vein and failure to correct the pathology in patients whose reflux exited the GSV along its transmission pathway. According to this issue, in this study, the investigators intend to investigate the different pathways of reflux transmission in chronic venous insufficiency patients who are candidates for GSV ablation/stripping because of saphenofemoral junction insufficiency according to the ultrasonographic exam. This cross-sectional study will be conducted with a descriptive-analytical approach on approximately 50 participants. Before surgery, patients are subjected to ultrasonographic mapping to check the pathway of reflux transmission and their related information is recorded. Other demographic information will also be recorded in the relevant checklist. Finally, the data will be analyzed in SPSS software.
- Conditions
- Venous Insufficiency
- Keywords
- venous insufficiency, reflux, ultrasonographic mapping, saphenofemoral junction
- Medical subject headings
- Venous Insufficiency, Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of reflux transmission pathways in CVI patients with SFJ incompetency
Determining the transmission pathways of reflux in patients with chronic venous insufficiency secondary to saphenofemoral reflux referring to vascular surgery clinics in Golestan province from 2022 to 2023
Measured: one year
Secondary outcomes (3)
Anatomic variations of GSV in CVI patients with SFJ incompetency
Determining the frequency of anatomical variations of the great saphenous vein in patients with chronic venous insufficiency secondary to saphenofemoral reflux
Measured: one year
Prevalence of reflux along GSV main trunk in CVI patients with SFJ incompetency
Determining the frequency of reflux in the main trunk of the great saphenous vein in patients with chronic venous insufficiency secondary to saphenofemoral reflux.
Measured: one year
Prevalence of reflux along accessory saphenous veins in CVI patients with SFJ incompetency
Determining the frequency of reflux along accessory saphenous veins in patients with chronic venous insufficiency secondary to saphenofemoral reflux.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start12 Sep 2023
- Primary completion15 Feb 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous InsufficiencyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golestan University of Medical sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pezhman Kharazm, MD, Golestan University of Medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369207
- Sponsor's protocol ID
- 113454
- Status last verified
- Sep 2024
- First submitted
- 12 Apr 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Reflux Transmission Pathways in Chronic Venous Insufficiency Patients Secondary to Saphenofemoral Reflux, Presenting to Vascular Surgery Clinics of Golestan Province From 2022 Till 2023
- ClinicalTrials.gov ID
- NCT06369207
- Acronym / sponsor ID
- 113454
- Conditions
- Venous Insufficiency
- Keywords
- venous insufficiency, reflux, ultrasonographic mapping, saphenofemoral junction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Golestan University of Medical sciencesUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 16 Apr 2024 (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.
Chronic venous insufficiency (CVI) is one of the most common medical problems in adults that occurs secondary to the reflux of blood through incompetent valves of lower extremity veins. The most common involved valve is the valve located at the saphenofemoral junction. Although the pathway of reflux transmission is not the same in all patients, the removal or ablation of the greater saphenous vein (GSV) is considered a standard treatment in these patients. However, in patients whose reflux is transmitted to branches other than GSV, this treatment leads to the unnecessary destruction of a competent segment of GSV in addition to remaining at least some segments of incompetent veins. So, in this study, the investigators intend to investigate the different pathways of reflux transmission in chronic venous insufficiency patients who are candidates for GSV ablation/stripping because of saphenofemoral junction insufficiency. This cross-sectional study will be conducted with a descriptive-analytical approach. .
Detailed description
Chronic venous insufficiency is one of the most common medical diseases in adults, which severely affects the quality of life of affected patients. What causes symptoms in this disease is the reflux of blood through incompetent valves located in the lower extremity veins. The most common cause is saphenofemoral valve insufficiency.
Although the pathway of reflux transmission is not the same in all patients, the removal of the greater saphenous vein (GSV) is considered a standard treatment according to the guidelines. This treatment leads to unnecessary destruction of the great saphenous vein and failure to correct the pathology in patients whose reflux exited the GSV along its transmission pathway. According to this issue, in this study, the investigators intend to investigate the different pathways of reflux transmission in chronic venous insufficiency patients who are candidates for GSV ablation/stripping because of saphenofemoral junction insufficiency according to the ultrasonographic exam. This cross-sectional study will be conducted with a descriptive-analytical approach on approximately 50 participants. Before surgery, patients are subjected to ultrasonographic mapping to check the pathway of reflux transmission and their related information is recorded. Other demographic information will also be recorded in the relevant checklist. Finally, the data will be analyzed in SPSS software.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All included participants are visited the day before surgery and venous mapping is performed for the patient by the vascular surgeon. The reflux pathway is marked on the skin and information regarding the anatomic characteristics of the reflux are recorded.
Key inclusion criteria (4 listed)
- Age>18.
- Chronic Venous Insufficiency with a clinical grade of 3 (varicosity) or more.
- Documentation of saphenofemoral junction insufficiency on Doppler ultrasound performed by a radiologist.
- Patient consent.
Key exclusion criteria (1 listed)
- History of DVT
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
Determination of reflux transmission pathways in CVI patients with SFJ incompetency
Time frame: one year
Determining the transmission pathways of reflux in patients with chronic venous insufficiency secondary to saphenofemoral reflux referring to vascular surgery clinics in Golestan province from 2022 to 2023
3 secondary outcomes
Anatomic variations of GSV in CVI patients with SFJ incompetency
Time frame: one year
Prevalence of reflux along GSV main trunk in CVI patients with SFJ incompetency
Time frame: one year
Prevalence of reflux along accessory saphenous veins in CVI patients with SFJ incompetency
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Insufficiency, run by Golestan University of Medical sciences at 1 site in Iran.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of reflux transmission pathways in CVI patients with SFJ incompetency (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2024.