Varicose Veins Clinical Trials

Find Varicose Veins Clinical Trials Near You

Comparação da eficácia clínica e estética Entre o Tratamento de Varizes Com Espuma de Polidocanol Associada ou não ao Laser transdérmico: Ensaio clínico Randomizado

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This randomized, parallel clinical trial with blinded outcome assessment will compare the clinical and aesthetic outcomes of polidocanol foam sclerotherapy alone versus polidocanol foam associated with long-pulse 1064 nm Nd:YAG transdermal laser in the treatment of lower-limb tributary varicose veins. The primary endpoint is venous occlusion rate at 30 days, assessed by Doppler ultrasound. Secondary outcomes include cutaneous hyperpigmentation, pain, patient satisfaction, and adverse events.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 75
Healthy Volunteers: f
View:

• Age 21 to 75 years

• CEAP clinical class 1-3

• Lower limb tributary varicose veins 2,5 to 4,0 mm in diameter on Doppler ultrasound.

• Vein depth up to 4 mm from the skin surface.

• Tributary vein may originate from the great or small saphenous vein as long as the saphenous vein is competent on Doppler.

• Reflux limited to the target tributary.

• Body mass index (BMI) \< 35 km²/m²

• Able and willing to provide informed consent.

Locations
Other Locations
Brazil
Hospital Universitário Pedro Ernesto - UERJ
RECRUITING
Rio De Janeiro
Contact Information
Primary
Juliana de Miranda Vieira, PhD
juliana.vieira@hupe.uerj.br
+ 55 21 99972 2885
Time Frame
Start Date: 2026-03-24
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 102
Treatments
Active_comparator: Group A: Foam only
Polidocanol 0,5% foam prepared with 1 mL of sclerosant and 3 mL of room air, injected under visualization of reticular vein (5 - 8 mL total).
Experimental: Group B: Foam + Laser
Polidocanol 0,25% foam (1 mL of sclerosant + 2 mL of room air) followed within 2 minutes by long-pulse Nd:YAG 1064 nm laser (spot 6 mm; pulse 20-30 ms; fluence 60-70 J/cm²), with skin cooling.
Related Therapeutic Areas
Sponsors
Leads: Hospital Universitario Pedro Ernesto

This content was sourced from clinicaltrials.gov

Similar Clinical Trials