NCT06124664 Study of Venous Outflow From the Lower Limbs in Patients With Pelvic Varicosities
| NCT ID | NCT06124664 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pirogov Russian National Research Medical University |
| Condition | Pelvic Varices |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-05-12 |
| Primary Completion | 2024-12-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2023-05-12 with a primary completion date of 2024-12-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Natalia V Koroleva, PhD
STUDY CHAIR
Pirogov Russian National Research Medical University
Frequently Asked Questions
Who can join the NCT06124664 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Pelvic Varices. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06124664 currently recruiting?
Yes, NCT06124664 is actively recruiting participants. Contact the research team at gavriloffsg@mail.ru for enrollment information.
Where is the NCT06124664 trial being conducted?
This trial is being conducted at Moskva, Russia.
Who is sponsoring the NCT06124664 clinical trial?
NCT06124664 is sponsored by Pirogov Russian National Research Medical University. The principal investigator is Natalia V Koroleva, PhD at Pirogov Russian National Research Medical University. The trial plans to enroll 90 participants.