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Laser Treatment Of Leg Telangiectasias

Primary Purpose

Leg Veins

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
1064 Nd:YAG laser
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Veins focused on measuring laser, telangiectasias, leg veins, sclerotherapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients with leg telangiectasias

Exclusion Criteria:

  • varicose veins
  • DVT
  • pregnancy

Sites / Locations

  • Vascular Surgery HCFMUSP

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

laser, leg veins, sclerotherapy

Arm Description

to compare laser and sclerotherapy on treating leg veins

Outcomes

Primary Outcome Measures

Changes analysis after treatments of leg telangiectasias´clearance through photography using a scale of improvement.
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).
Changes analysis after treatments of leg telangiectasias´clearance using a questionnaire to classify the pain
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).
Changes analysis after treatments of leg telangiectasias´clearance using a questionnaire to classify the cleaning of vessels
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)
Changes analysis after treatments of leg telangiectasias´clearance using a questionnaire to classify the satisfaction with results
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

Secondary Outcome Measures

Full Information

First Posted
September 21, 2011
Last Updated
June 27, 2019
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04004728
Brief Title
Laser Treatment Of Leg Telangiectasias
Official Title
Aavaliação do Tratamento de Telangiectasias Dos Membros Inferiores Com Laser 1064mm
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Is 1064 nm YAG Laser better than sclerotherapy to treat leg veins?
Detailed Description
Comparison between laser and sclerotherapy in the treatment of telangiectasias of legs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Veins
Keywords
laser, telangiectasias, leg veins, sclerotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One leg laser ando the other sclerotherapy.
Masking
None (Open Label)
Masking Description
Blind photo evaluation.
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laser, leg veins, sclerotherapy
Arm Type
Other
Arm Description
to compare laser and sclerotherapy on treating leg veins
Intervention Type
Procedure
Intervention Name(s)
1064 Nd:YAG laser
Intervention Description
1064 laser - 135J 25ms spot 3mm GLicose - 75% - 3 ml
Primary Outcome Measure Information:
Title
Changes analysis after treatments of leg telangiectasias´clearance through photography using a scale of improvement.
Description
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).
Time Frame
Analysis of photographic changes previous, and one week after treatment. Patient reanalysis after 1 and 3 months
Title
Changes analysis after treatments of leg telangiectasias´clearance using a questionnaire to classify the pain
Description
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).
Time Frame
1 week after treatment
Title
Changes analysis after treatments of leg telangiectasias´clearance using a questionnaire to classify the cleaning of vessels
Description
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)
Time Frame
1 week after treatment
Title
Changes analysis after treatments of leg telangiectasias´clearance using a questionnaire to classify the satisfaction with results
Description
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
Time Frame
1 week after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients with leg telangiectasias Exclusion Criteria: varicose veins DVT pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelson Wolosker, MD, PhD
Organizational Affiliation
Hospital das Clinicas, University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Vascular Surgery HCFMUSP
City
Sao Paulo
ZIP/Postal Code
04534000
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Laser Treatment Of Leg Telangiectasias

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