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

Varicose Veins Clinical Trial

Official title:

A Randomized Triple-blind Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Sclerotherapy in Treatment of Reticular Veins at the Lower Limbs.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02054325
• Other study ID #: CEP 4127.2012
• Status: Recruiting
• Phase: Phase 4
• First received: February 1, 2014
• Last updated: February 3, 2014
• Start date: September 2012
• Est. completion date: August 2014

Study information

• Verified date: February 2014
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: Matheus Bertanha, Professor
• Phone: +55 14 38116305
• Email: matheus.fameca[@]ig.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Drug:
• Polidocanol with Glucose
An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects
• Glucose
An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects

Locations

Country	Name	City	State
Brazil	School of Medicine at Botucatu- Paulista State University- UNESP, São Paulo, Brazil	Botucatu	SP

Sponsors (2)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy in treating reticular veins in the lower limbs	Photographs will be performed pretreatment and two months after the treatment, these will be analyzed for efficacy in treat reticular veins treated subjectively by two blind analyzers and objectively by another analyzer with measurement through the use of free software ImageJ	The primary endpoint will be evaluated in two months	No
Secondary	The safety of the treatment will be evaluated	Photographs will be performed pretreatment, a week after the treatment, and two months later. It will be performed clinical and photographic assessment of possible adverse effects.	One week of treatment and two months of treatment.	Yes