Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins

UPECLIN HC FM Botucatu Unesp

Status and phase

Completed

Phase 4

Conditions

Varicose Veins

Treatments

Drug: Polidocanol with Glucose

Drug: Glucose

Study type

Interventional

Funder types

Other

Identifiers

NCT02054325

CEP 4127.2012

Details and patient eligibility

About

It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75% hypertonic glucose of sclerotherapy in lower limbs´ reticular veins. It will be included only adult women with reticular veins on the side of the thighs and mild venous insufficiency (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.

Full description

Background. The prevalence of chronic venous disease is high in the general population, mainly in young women, and in milder cases the usual complaint is aesthetic. Various techniques are used for treatment of mild varicose disease, including surgical treatment, laser ablation and sclerotherapy. Reticular veins are those with less than 3mm diameter, bluish and important contribution to the aesthetic damage, and sometimes they are related to local pain and recurrence after treatment of telangiectasias. There is no consensus in the literature about the effectiveness of treatment with sclerotherapy, despite of being an usual procedure with different chemicals.

Methods and design. One hundred lower limbs of healthy women between 18 and 69 years will be triple blind randomized to receive treatment with polidocanol 0.2% diluted in 70% hypertonic glucose versus 75% hypertonic glucose for sclerotherapy treatment of reticular veins. The patients will be examined and clinically classified. It will be included patients with reticular veins sited at out's thigh/leg, measuring at least 10cm long, and only one extremity will be included per patient. The patients with varicose disease CEAP 2 or more will not be included. The treatment will be carried out in only one session and the medication volume not exceeding 5 ml. Clinical follow-up protocols will be filled on regular visits on days 0 - 7 - 60 concomitantly with photograph documentation. Supplementary examination for venous mapping with ultrasound pretreatment is performed for all patients.

Discussion. This prospective controlled double-blind randomized trial aims to verify and compare the efficacy and safety for sclerotherapy treatment of reticular veins of the lower limbs. The results may help physicians to choose the best sclerotherapy treatment for reticular veins.

Enrollment

106 patients

Sex

Female

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

females
with at least 10 cm from the lateral reticular veins of the leg or thigh of the leg
clinical classification of chronic venous disease C1(mild venous disease),
minimum age of 18 year-old and maximum age 69 year-old
agreement with the study
signing the free and informed consent ( IC)
not use anticoagulant drugs .

Exclusion criteria

male
varicose disease in any quantity or location with clinical classification of chronic venous disease different of C1(mild venous disease)
restrict mobility
arterial insufficiency
be allergic to any substance that may be related to the study drugs
any cause of dermatitis on application site
free of comorbidities clinically serious as diabetes mellitus, heart failure, respiratory failure, uncontrolled hypertension with medication, and uncontrolled hypothyroidism
pregnancy
previous deep vein thrombosis (DVT)
family history of DVT
thrombophilia
do not agree with the search terms