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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date changed from estimate of Aug 29, 2024 to Dec 25, 2024
    • Study completion date: Dec 2024 to Dec 25, 2024
    • Start date: May 4, 2023 to May 12, 2023
    v3
  2. Notable Primary completion date: Nov 2023 to Aug 29, 2024
    • Study completion date: Dec 2023 to Dec 2024
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06124664
Lead Sponsor Pirogov Russian National Research Medical University
Conditions
(from sponsor)
Pelvic Varices, Varicose Veins of Lower Limb, Pelvic Pain Syndrome, Pelvic Congestive Syndrome
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov