Varicose veins
Conditions
Interventions
This is a randomized, controlled clinical trial with two parallel arms. Eligible participants will be randomly allocated in a 1:1 ratio to one of the two intervention groups using a computer-generated
Sponsors
Universidade do Estado do Rio de Janeiro (UERJ) – Hospital Universitário Pedro Ernesto (HUPE)
Universidade do Estado do Rio de Janeiro (UERJ) – Hospital Universitário Pedro Ernesto (HUPE)
Eligibility
Age
21 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age between 21 and 75 years of both sexes. Superficial lower limb tributary varicose veins with a diameter between 2.5 mm and 4.0 mm assessed in the standing position. Tributary vein depth up to 4 mm measured from the anterior wall of the vein to the skin surface. Tributary varicose veins related to the saphenous vein provided that the saphenous vein is competent on Doppler ultrasound. CEAP clinical classification 1 to 3. Body mass index less than 35 kg/m². Signed informed consent form.
Exclusion criteria
Exclusion criteria: Body mass index greater than 35 kg/m². Saphenous vein incompetence requiring prior treatment. CEAP clinical classification 4 to 6. Active venous thromboembolic disease or history of deep vein thrombosis. Active malignancy or immunosuppression. Active rheumatologic diseases or lymphedema. Known allergy to polidocanol. Skin lesions at the site of the vein to be treated. Pregnancy or postpartum period. Inability to understand or sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete venous occlusion rate of the treated segment, assessed 30 days after the first treatment session by Doppler ultrasound performed by a blinded evaluator. | — |
Secondary
| Measure | Time frame |
|---|---|
| Final venous occlusion after up to two treatment sessions, assessed by Doppler ultrasound.;Cutaneous hyperpigmentation along the treated vein trajectory, assessed at 30, 90, and 180 days using standardized photographs evaluated by blinded assessors.;Procedure-related pain, assessed immediately after each session using a visual analog scale (VAS).;Number of treatment sessions required to achieve complete venous occlusion.;Patient aesthetic satisfaction, assessed after treatment.;Procedure-related adverse events. | — |
Countries
Brazil
Contacts
Public ContactJuliana Vieira
Universidade do Estado do Rio de Janeiro (UERJ) – Hospital Universitário Pedro Ernesto (HUPE)
Outcome results
None listed