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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by UPECLIN HC FM Botucatu Unesp
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Dr Matheus Bertanha, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT02054325
First received: February 1, 2014
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Varicose Veins
Drug: Polidocanol with Glucose
Drug: Glucose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Triple-blind Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Sclerotherapy in Treatment of Reticular Veins at the Lower Limbs.

Resource links provided by NLM:


Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • Efficacy in treating reticular veins in the lower limbs [ Time Frame: The primary endpoint will be evaluated in two months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • The safety of the treatment will be evaluated [ Time Frame: One week of treatment and two months of treatment. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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
Active Comparator: Glucose
An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.
Drug: 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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02054325

Contacts
Contact: Matheus Bertanha, Professor +55 14 38116305 matheus.fameca@ig.com.br
Contact: Marcone L. Sobreira, Professor +55 14 38116305 mlsobreira@gmail.com

Locations
Brazil
School of Medicine at Botucatu- Paulista State University- UNESP, São Paulo, Brazil Recruiting
Botucatu, SP, Brazil, 18607030
Contact: Matheus Bertanha, Professor    +55 14 38116305    matheus.fameca@ig.com.br   
Contact: Marcone L Sobreira, Professor    +55 14 38116305    mlsobreira@gmail.com   
Principal Investigator: Matheus Bertanha, Professor         
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Matheus Bertanha, Professor UPECLIN HC FM Botucatu Unesp
  More Information

No publications provided

Responsible Party: Dr Matheus Bertanha, Professor, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier: NCT02054325     History of Changes
Other Study ID Numbers: CEP 4127.2012
Study First Received: February 1, 2014
Last Updated: February 3, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by UPECLIN HC FM Botucatu Unesp:
Sclerotherapy
varicose veins
veins

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Polidocanol
Sclerosing Solutions
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on August 27, 2014