Laser Treatment Of Leg Telangiectasias

June 27, 2019 updated by: Nelson Wolosker, University of Sao Paulo

Aavaliação do Tratamento de Telangiectasias Dos Membros Inferiores Com Laser 1064mm

Is 1064 nm YAG Laser better than sclerotherapy to treat leg veins?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comparison between laser and sclerotherapy in the treatment of telangiectasias of legs.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04534000
        • Vascular Surgery HCFMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with leg telangiectasias

Exclusion Criteria:

  • varicose veins
  • DVT
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: laser, leg veins, sclerotherapy
to compare laser and sclerotherapy on treating leg veins
Procedure: 1064 Nd:YAG laser
1064 laser - 135J 25ms spot 3mm GLicose - 75% - 3 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes analysis after treatments of leg telangiectasias´clearance through photography using a scale of improvement.
Time Frame: Analysis of photographic changes previous, and one week after treatment. Patient reanalysis after 1 and 3 months
Patients are asked about the best method to treat leg veins after three treatments of laser and three treatments of sclerotherapy. Evaluation of the photographic improvement of the treated areas on a scale of 0 (no improvement) to 10 (complete cleaning of the vessels).
Analysis of photographic changes previous, and one week after treatment. Patient reanalysis after 1 and 3 months
Changes analysis after treatments of leg telangiectasias´clearance using a questionnaire to classify the pain
Time Frame: 1 week after treatment
Patients are asked about the best method to treat leg veins after three treatments of laser. All patients were asked to respond to a questionnaire classifying the pain (none, little, very painful or extremely painful).
1 week after treatment
Changes analysis after treatments of leg telangiectasias´clearance using a questionnaire to classify the cleaning of vessels
Time Frame: 1 week after treatment
Patients are asked about the best method to treat leg veins after three treatments of laser. All patients were asked to respond to a questionnaire classifying the cleaning of vessels (poor, regular, good or excellent)
1 week after treatment
Changes analysis after treatments of leg telangiectasias´clearance using a questionnaire to classify the satisfaction with results
Time Frame: 1 week after treatment
Patients are asked about the best method to treat leg veins after three treatments of laser. All patients were asked to respond to a questionnaire classifying satisfaction with results (nothing, little or much
1 week after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Study Director: Nelson Wolosker, MD, PhD, Hospital das Clinicas, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

September 21, 2011

First Submitted That Met QC Criteria

June 27, 2019

First Posted (Actual)

July 2, 2019

Study Record Updates

Last Update Posted (Actual)

July 2, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSR 0072/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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