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Study comparing two treatments with Laser for Lower Limb Microvarices

Transdermal Laser Association comparing two treatments of Sclerotherapy for the Treatment of Unesthetic Veins of Lower Limbs: Triple Blind Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-949wrsh
Enrollment
Unknown
Registered
2023-01-09
Start date
2021-01-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic varicose veins of lower extremities

Interventions

This is a randomized, controlled, two-arm, triple-blind, clinical trial, in a 1: 1(26 patients for the Laser + glucose group and 25 patients for the Laser + polidocanol solution) ratio to undergo trea
E02.319.805

Sponsors

Clinica Prime Vascular
Lead Sponsor
Clinica Prime Vascular
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Volunteers women; aged between 18 and 70 years; reticular veins and telangiectasias; without reflux of the deep venous or saphenous system; Fitzpatrick Skin Type I, II or III; Patients should have at least one reticular vein with a minimum length of 5 cm in one of the lower limbs on the lateral side of the thigh.

Exclusion criteria

Exclusion criteria: Venous disease CEAP class greater than C1; who underwent procedure with sclerotherapy or transdermal laser in the last 12 months; skin classification Fitzpatrick IV, V or VI; pregnancy or puerperium; known allergy; peripheral arterial disease; diabetes; dermatitis at the treatment site; asthma; migraine; deep or superficial deep vein thrombosis (DVT); family history of DVT; known thrombophilia or any hypercoagulable state and use of anticoagulants.

Design outcomes

Primary

MeasureTime frame
Expected Outcome 1:It is expected to find disappearance of the reticular vein and the clearing of the telangiectasia veins in the treatment area after 30 days of treatment, verified by means of photographs, with the use of transdermal laser associated with the sclerosing solution.;Expected Found 1: The association of Nd:YAG laser to sclerotherapy with 67.5% Glucose solution + 0.3% Polidocanol was superior for the treatment of reticular veins compared to the use of Nd:YAG laser and sclerotherapy with hyperchromic glucose alone in eliminating reticular veins from the treatment zone (76% vs 46.1%; p 0.05) and regarding the complications (0% vs 3.8%; p> 0.05).—

Secondary

MeasureTime frame
No secondary outcomes expected—

Countries

Brazil

Contacts

Public ContactMarcos Fonseca

Clinica Prime Vascular

marcosmaraskinfonseca@gmail.com+55 51 3737-0074

Outcome results

None listed

Source: REBEC (via WHO ICTRP)