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

RecruitingNCT06124664
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Compression therapy is basic treatment for chronic venous disease (CVD) of the lower limbs. Numerous studies have demonstrated the efficacy and safety of compression therapy in relieving symptoms such as pain, venous edema, leg heaviness and fatigue, as well as accelerating the healing of venous ulcers. It has been established that сompression therapy is indicated for patients with both minimally expressed manifestations of CVD and severe forms of the disease. At the same only one study has been conducted to assess the correction of venous outflow from the lower limbs and pelvis in patients with pelvic varicose vein (PVV) and pelvic congestion syndrome (PCS). However, the incidence of this pathology ranges from 15 to 30% in the female population. The cost to the healthcare system of treating these patients in the United States exceeds $2 billion. To date, the options and indications for compression therapy in patients with concomitant PVV and CVD have not been defined. The rational use of compression in this cohort of patients may contribute to the improvement of effective conservative treatment. In addition, inappropriate prescription of compression to patients with pelvic venous disease (which can be observed in real clinical practice) may discredit this simple, effective and safe therapeutic method. In addition, the research devoted to the problem of compression treatment of PVV will contribute to the development of new special compression products aimed at accelerating venous outflow from the pelvic organs. It can be assumed that this will serve as a stimulus for obtaining new data on the therapeutic effects of compression and create conditions for the creation of new technological directions in the production of compression knitwear.

Study details

Official title
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
Conditions
  • Pelvic Varices
  • Varicose Veins of Lower Limb
  • Pelvic Pain Syndrome
  • Pelvic Congestive Syndrome
Interventions
  • Diagnostic test: Radionuclide venography
  • Diagnostic test: single-photon emission computed tomography
Sponsor
Pirogov Russian National Research Medical University
Start date
2023-05-12
Primary completion
2024-12-25
Sex
Female
Age range
from 18 Years to 40 Years
Results posted
No results posted in this snapshot
Countries
Russia
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patient age from 18 to 40 years; * Presence of pelvic varicose veins according to DUS data; * Reflux in the pelvic veins for more than 1 second before this DUS; * Reflux in the superficial veins of the lower limbs. Exclusion Criteria: * Menopause; * Pregnancy; * Postthrombotic disease; * Suspicion of May-Turner syndrome; * Ultrasound signs of nutcracker syndrome

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06124664