Laser Treatment Of Leg Telangiectasias

NCT04004728 | Completed DMC

• 1 other identifier: LSR 0072/09
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Leg Veins

Keywords

laser; telangiectasias; leg veins; sclerotherapy

Outcome Measures

Primary Outcomes (4)

• 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).

  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

  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

  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

  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

Study Arms (1)

laser, leg veins, sclerotherapy

OTHER

to compare laser and sclerotherapy on treating leg veins

Procedure: 1064 Nd:YAG laser

Interventions

1064 Nd:YAG laser PROCEDURE

1064 laser - 135J 25ms spot 3mm GLicose - 75% - 3 ml

laser, leg veins, sclerotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with leg telangiectasias

You may not qualify if:

• varicose veins
• DVT
• pregnancy

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Vascular Surgery HCFMUSP

São Paulo, 04534000, Brazil

Location

MeSH Terms

Conditions

Telangiectasis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nelson Wolosker, MD, PhD

  Hospital das Clinicas, University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blind photo evaluation.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor, MD, PhD

Model Details: One leg laser ando the other sclerotherapy.

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: July 2, 2019
• Study Start: March 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 2, 2019

Record last verified: 2019-06

Locations

BR (1)