Treatment of Leg Telangiectasias With Nd:YAG 1064nm

May 5, 2010 updated by: Grupo de Cirurgia Vascular
Studying the results of treatment of dilated vessels of the lower limbs with laser, and compare them to those obtained with sclerotherapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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
        • Hospital das Clinicas da FMUSP

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with leg telangiectasias

Exclusion Criteria:

  • Arterial disease
  • Varices
  • Diabetes

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser Nd:YAG 1064nm
Patients with leg telangiectasias are treated with 3 sessions of Nd:YAG 1064nm, with 14 days interval
Device: Laser Nd:YAG 1064nm
Patients with leg telangiectasias are treated with 3 sessions of Nd:YAG 1064nm, with 14 days interval
Other Names:
  • laser
  • Xeo
  • Cool Glide
Active Comparator: Sclerotherapy
Patients with leg telangiectasias are treated with 3 sessions of sclerotherapy, with 14 days interval
Other: Sclerotherapy
Patients with leg telangiectasias are treated with 3 sessions of sclerotherapy, with 14 days interval
Other Names:
  • glicose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment of leg telangiectasias
Time Frame: first day
Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.
first day
Treatment of telangiectasias
Time Frame: 1 month
Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of adverse effects
Time Frame: after 1 month
Patients are monitored to adverse effects such as blemishes, scars and ulcers
after 1 month
Pain Scores on the Visual Analog Scale
Time Frame: After 1 month
Patients evaluate pain on the Visual Analog Scale
After 1 month

Collaborators and Investigators

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

Sponsor

Grupo de Cirurgia Vascular

Investigators

  • Study Chair: Nelson Wolosker, MD, PhD, Hospital das Clinicas, University of Sao Paulo
  • Principal Investigator: Marco Munia, MD, Hospital das Clinicas, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

April 29, 2010

First Submitted That Met QC Criteria

May 5, 2010

First Posted (Estimate)

May 6, 2010

Study Record Updates

Last Update Posted (Estimate)

May 6, 2010

Last Update Submitted That Met QC Criteria

May 5, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 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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