Polidocanol Versus Glucose Treatment of Telangiectasia Trial

NCT02657252 | Completed Phase 4 Results DMC

• 1 other identifier: UPECLIN
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Varicose Veins; Telangiectasis

Keywords

telangiectasis; varicose veins; veins; glucose; sclerotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Skin Hyperpigmentation

  2 months

• Number of Participants With Deep Venous Thrombosis (DVT)

  1 week

Study Arms (2)

Glucose

ACTIVE COMPARATOR

An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis 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

Drug: Glucose

Polidocanol with Glucose

ACTIVE COMPARATOR

An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis 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

Drug: Polidocanol with Glucose

Interventions

Glucose DRUG

Sclerotherapy of telangiectasis in one lower limb.

Also known as: Hypertonic dextrose

Glucose

Polidocanol with Glucose DRUG

Sclerotherapy of telangiectasis in one lower limb.

Also known as: Asclera, Varithena

Polidocanol with Glucose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Vascular Lab

Botucatu, São Paulo, 18618687, Brazil

Location

Related Publications (1)

• Bertanha M, Camargo PA, Moura R, Yoshida WB, Pimenta RE, Mariuba JV, Alcantara GP, de Paula DR, Sobreira ML. Polidocanol versus glucose in the treatment of telangiectasia of the lower limbs (PG3T): Protocol for a randomized, controlled clinical trial. Medicine (Baltimore). 2016 Sep;95(39):e4812. doi: 10.1097/MD.0000000000004812.

  PMID: 27684809 DERIVED

MeSH Terms

Conditions

Varicose Veins; Telangiectasis

Interventions

Glucose; Polidocanol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Matheus Bertanha
• Organization: UPECLIN

matheus.fameca@ig.com.br

+551438116305

Study Officials

• Matheus Bertanha, Dr

  Botucatu School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 15, 2016
• Study Start: January 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 4, 2018
• Results First Posted: November 28, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)