Polidocanol Versus Glucose Treatment of Telangiectasia Trial

Varicose Veins Clinical Trial

— PG3T  

Official title:

Polidocanol Versus Glucose For Sclerotherapy Treatment Of Telangiectasia Of The Lower Limbs: Protocol For A Randomized, Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657252
• Other study ID #: UPECLIN
• Status: Completed
• Phase: Phase 4
• First received: January 7, 2016
• Last updated: November 30, 2017
• Start date: January 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2017
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• 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´ telangiectasis. 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. Telangiectasis are those with less than 1 mm diameter, reddish and important contribution to the aesthetic damage, and sometimes they are related to local pain. 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 65 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 telangiectasis. The patients will be examined and clinically classified. It will be included patients with telangiectasis sited at out's thigh, 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 telangiectasis of the lower limbs. The results may help physicians to choose the best sclerotherapy treatment for telangiectasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: November 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• females

• with telangiectasis on thigh side

• clinical classification of chronic venous disease C1(mild venous disease),

• minimum age of 18 year-old and maximum age 65 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

• don´t be 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

Related Conditions & MeSH terms

• Telangiectasis
• Varicose Veins

Intervention

Drug:
• Glucose
Sclerotherapy of telangiectasis in one lower limb.
• Polidocanol with Glucose
Sclerotherapy of telangiectasis in one lower limb.

Locations

Country	Name	City	State
Brazil	Vascular Lab	Botucatu	São Paulo

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	Change From Baseline in Extent of Telangiectasias	Efficiency in promoting the disappearance of the treated telangiectasias, making the comparison between the initial measurements in centimeters and after two months, then comparing the treatment between the two treatments	2 months
Secondary	Skin Hyperpigmentation	Observed after two months of treatment the occurrence of hyperpigmentation stains in the treated areas. Measuring in centimeters those stains and compare the two treatments together.	2 months
Secondary	Number of Participants With Deep Venous Thrombosis (DVT)	Observe after one week of treatment occurred if clinical signs and symptoms of deep vein thrombosis (DVT) and perform duplex ultrasound for confirmation. Compare the results between the two groups to establish a security policy.	1 week