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Treatment of Leg Telangiectasias With Nd:YAG 1064nm

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ClinicalTrials.gov Identifier: NCT01118390
Recruitment Status : Unknown
Verified August 2009 by Grupo de Cirurgia Vascular.
Recruitment status was:  Enrolling by invitation
First Posted : May 6, 2010
Last Update Posted : May 6, 2010
Sponsor:
Information provided by:
Grupo de Cirurgia Vascular

Brief Summary:
Studying the results of treatment of dilated vessels of the lower limbs with laser, and compare them to those obtained with sclerotherapy.

Condition or disease Intervention/treatment Phase
Telangiectasias Device: Laser Nd:YAG 1064nm Other: Sclerotherapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Leg Telangiectasias With Nd:YAG 1064nm
Study Start Date : August 2009
Actual Primary Completion Date : March 2010
Estimated Study Completion Date : July 2010

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 Name: glicose



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

  2. 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 :
  1. Presence of adverse effects [ Time Frame: after 1 month ]
    Patients are monitored to adverse effects such as blemishes, scars and ulcers

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



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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

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