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CompletedNCT06369207Updated Sep 20, 2024

Investigation of the Transmission Pathways of Reflux in Patients With Chronic Venous Insufficiency

An observational study in Venous Insufficiency, sponsored by Golestan University of Medical sciences. Completed at 1 site in Iran. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-20.

Sponsored by Golestan University of Medical sciences · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Venous Insufficiency

Keywords

  • venous insufficiency
  • reflux
  • ultrasonographic mapping
  • saphenofemoral junction
03

In context

Venous Insufficiency

193 studies on the registry are indexed under Venous Insufficiency; 15 are open to participants now.

This study's enrollment of 50 is below the median of 95 across 42 observational studies indexed under Venous Insufficiency.

Browse Venous Insufficiency studies →

Lead sponsor

Golestan University of Medical sciences is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

- History of DVT

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: one year

Secondary outcomes

  1. 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

    Time frame: one year

  2. 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.

    Time frame: one year

  3. 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.

    Time frame: one year

07

Study locations

1 site
  • Pezhman Kharazm, MD
    Gorgan, Golestan Province 4917956808, Iran
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06369207
Lead sponsor
Golestan University of Medical sciences
Responsible party
Pezhman Kharazm, MD (Vascular Surgeon, Golestan University of Medical sciences) — Principal investigator
First posted
Apr 16, 2024
Start date
Sep 12, 2023
Primary completion
Feb 15, 2024
Completion
Sep 15, 2024
Last update
Sep 20, 2024

Oversight

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

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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