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Treatment of Leg Telangiectasias With Nd:YAG 1064nm

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Grupo de Cirurgia Vascular.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01118390
First Posted: May 6, 2010
Last Update Posted: May 6, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Grupo de Cirurgia Vascular
  Purpose
Studying the results of treatment of dilated vessels of the lower limbs with laser, and compare them to those obtained with sclerotherapy.

Condition Intervention
Telangiectasias Device: Laser Nd:YAG 1064nm Other: Sclerotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Leg Telangiectasias With Nd:YAG 1064nm

Further study details as provided by Grupo de Cirurgia Vascular:

Primary Outcome Measures:
  • treatment of leg telangiectasias [ Time Frame: first day ]
    Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.

  • Treatment of telangiectasias [ Time Frame: 1 month ]
    Patients respond after treatment a questionnaire about satisfaction for both the laser and for conventional sclerotherapy.


Secondary Outcome Measures:
  • Presence of adverse effects [ Time Frame: after 1 month ]
    Patients are monitored to adverse effects such as blemishes, scars and ulcers

  • Pain Scores on the Visual Analog Scale [ Time Frame: After 1 month ]
    Patients evaluate pain on the Visual Analog Scale


Enrollment: 30
Study Start Date: August 2009
Estimated Study Completion Date: July 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: glicose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with leg telangiectasias

Exclusion Criteria:

  • Arterial disease
  • Varices
  • Diabetes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118390


Locations
Brazil
Hospital das Clinicas da FMUSP
Sao Paulo, Brazil, 04534000
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Marco Antonio Munia, Departamento de Cirurgia Vascular HCFMUSP
ClinicalTrials.gov Identifier: NCT01118390     History of Changes
Other Study ID Numbers: 0072/09
First Submitted: April 29, 2010
First Posted: May 6, 2010
Last Update Posted: May 6, 2010
Last Verified: August 2009

Keywords provided by Grupo de Cirurgia Vascular:
telangiectasias
leg
sclerotherapy
laser
glycose

Additional relevant MeSH terms:
Telangiectasis
Vascular Diseases
Cardiovascular Diseases