Overview

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

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UPECLIN HC FM Botucatu Unesp
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Treatments:
Polidocanol
Criteria
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