Actively Recruiting

Age: 18Years - 40Years
FEMALE
ID06124664

Study of Venous Outflow From the Lower Limbs in Patients With Pelvic Varicosities as a New Strategy for Compression Treatment of Pelvic Varicose Veins and Varicose Veins of the Lower Limb

Led by Pirogov Russian National Research Medical University · Updated on 2024-12-27

90

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the effects of pelvic varicose veins (PVV) and pelvic congestion syndrome (PCS) on venous outflow from the lower limbs in women with chronic venous disease (CVD). This observational study aims to understand how symptomatic and asymptomatic PVV impact the clinical course of CVD and the potential role of compression therapy. The study addresses the relationship between pelvic and lower limb varicose veins, including their frequency, symptoms, and hemodynamic disturbances, to improve treatment strategies and develop targeted compression products. The study includes three groups: 40 women with symptomatic PVV without signs of CVD, 40 women with asymptomatic PVV showing signs of CVD, and 10 women with varicose veins of the lower limb without PVV or PCS. Participants undergo diagnostic tests including radionuclide venography and single-photon emission computed tomography (SPECT) to assess venous outflow and pelvic venous congestion. The study duration is from May 2023 to January 2024, focusing on measuring isotope transport time and the coefficient of pelvic venous congestion. Participants will be monitored through imaging studies and clinical assessments at baseline and after 10 days. Researchers will evaluate venous blood flow, pelvic vein reflux, and symptoms related to pelvic congestion. The main outcomes include the average transport time of an injected isotope and a quantitative pelvic venous congestion coefficient. These results will help clarify the role of compression therapy and venous outflow disorders in women with PVV and CVD, aiming to improve conservative treatment options and clinical management.

CONDITIONS

Brief Title

Study of Venous Outflow From the Lower Limbs in Patients With Pelvic Varicosities

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient age from 18 to 40 years
  • Presence of pelvic varicose veins confirmed by duplex ultrasound scanning (DUS)
  • Reflux in the pelvic veins lasting more than 1 second before DUS
  • Reflux in the superficial veins of the lower limbs
Not Eligible

You will not qualify if you...

  • Menopause
  • Pregnancy
  • Postthrombotic disease
  • Suspicion of May-Turner syndrome
  • Ultrasound signs of nutcracker syndrome

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 1 day

Participants undergo radionuclide venography and single-photon emission computed tomography (SPECT) to assess venous outflow from the lower limbs and pelvic veins.

1 visit (in-person)

Long-term Monitoring

Duration - 10 days

Participants are observed to evaluate venous outflow characteristics and clinical manifestations over time without receiving active treatment.

1 follow-up visit

Trial Site Locations

Total: 1 location

1

Ananstsia Grishenkova

Moskva, Russia, 119049

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Research Team

S

Sergey G Gavrilov, MD, PhD

A

Anatoly V Karalkin, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

The relation between pelvic varicose veins, chronic pelvic pain and lower extremity venous insufficiency in women.

Neslihan Zehra Gültaşli, Aydin Kurt, Ali Ipek...

https://pubmed.ncbi.nlm.nih.gov/16538582

Pelvic venous reflux is a major contributory cause of recurrent varicose veins in more than a quarter of women.

Alice M Whiteley, Daniel C Taylor, Scott J Dos Santos...

https://pubmed.ncbi.nlm.nih.gov/26993547