Comparing laser treatment and sclerotherapy for reticular leg veins
Treatment of Reticular Leg Veins: a Prospective, Randomized, Comparative Clinical Trial of a 1064 nm Nd:YAG Long Pulse Laser, Combined Treatment of a 1064 nm Nd:YAG Long Pulse Laser and Sclerotherapy vs. Sclerotherapy Alone.
This study is testing whether a new laser treatment for reticular leg veins works as well as the traditional sclerotherapy, and it will also look at how patients feel about each option and any side effects they might have.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 174 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Derzhavin Tambov State University Academic / other |
| Locations | 1 site (Tambov) |
| Trial ID | NCT06175754 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a 1064 nm long-pulsed Nd:YAG laser treatment for reticular leg veins compared to traditional sclerotherapy. It aims to determine if the laser treatment, either alone or in combination with sclerotherapy, is as effective as sclerotherapy alone while also analyzing the frequency of adverse events associated with each method. The study is designed as a prospective, randomized, comparative clinical trial, which is currently lacking in existing literature. By assessing patient satisfaction and side effects, the study seeks to identify the most advantageous treatment option for reticular leg veins.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 years old with reticular veins who can provide informed consent.
Not a fit: Patients with conditions such as diabetes, pregnancy, or certain chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective and safer treatment option for reticular leg veins, potentially reducing adverse effects and improving satisfaction.
How similar studies have performed: While there have been studies comparing laser treatment and sclerotherapy, this specific comparative approach is novel and has not been extensively tested in a prospective, randomized format.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * women over 18 * reticular veins * signed informed consent to participate in the study Exclusion Criteria: * diabetes mellitus * pregnancy or lactation * malignant neoplasms * inability or unwillingness of the patient to wear compression stockings * hypersensitivity to the polidocanol, cold, sunlight * concomitant diseases: bronchial asthma, severe liver and kidney disease, acute thrombosis and thrombophlebitis, infection of the skin and/or soft tissues, infectious diseases, arteriosclerosis, diabetic angiopathy, heart defects requiring surgery, fever, toxic hyperthyroidism, obesity, tuberculosis, sepsis, violation of the cellular composition of the blood, all diseases requiring bed rest, heart disease with decompensation phenomena, * known hereditary thrombophilia. * period after treatment of alcoholism * reception of oral contraceptives * sedentary lifestyle
Where this trial is running
Tambov
- Bukina Oksana Vasilyevna — Tambov, Russia (Recruiting)
Study contacts
- Principal investigator: Oksana V Bukina, PhD — Derzhavin Tambov State University
- Study coordinator: Oksana V Bukina, PhD
- Email: ovsafonova@yandex.ru
- Phone: +79051204983
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.