Leg VeinsNCT04004728
Laser Treatment Of Leg Telangiectasias
A study testing 1064 Nd:YAG laser in people with Leg Veins, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Is 1064 nm YAG Laser better than sclerotherapy to treat leg veins? Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leg Veins
- What is being tested?
- 1064 Nd:YAG laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with leg telangiectasias
Who cannot join
- varicose veins
- DVT
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aavaliação do Tratamento de Telangiectasias Dos Membros Inferiores Com Laser 1064mm
Is 1064 nm YAG Laser better than sclerotherapy to treat leg veins?
Read the detailed description
Comparison between laser and sclerotherapy in the treatment of telangiectasias of legs.
- Conditions
- Leg Veins
- Being tested
- 1064 Nd:YAG laser
- Keywords
- laser, telangiectasias, leg veins, sclerotherapy
- Medical subject headings
- Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1064 Nd:YAG laserProcedure or surgery
1064 laser - 135J 25ms spot 3mm GLicose - 75% - 3 ml
| Study group | Role | What they receive |
|---|---|---|
| laser, leg veins, sclerotherapy | Other | to compare laser and sclerotherapy on treating leg veins Receives: Procedure: 1064 Nd:YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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)
Measured: 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
Measured: 1 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study startMar 2010
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg VeinsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One leg laser ando the other sclerotherapy.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelson Wolosker, University of Sao Paulo
- Investigators
- Nelson Wolosker, MD, PhD, Study director, Hospital das Clinicas, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004728
- Sponsor's protocol ID
- LSR 0072/09
- Status last verified
- Jun 2019
- First submitted
- 21 Sep 2011
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aavaliação do Tratamento de Telangiectasias Dos Membros Inferiores Com Laser 1064mm
- ClinicalTrials.gov ID
- NCT04004728
- Acronym / sponsor ID
- LSR 0072/09
- Conditions
- Leg Veins
- Keywords
- laser, telangiectasias, leg veins, sclerotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One leg laser ando the other sclerotherapy.
| Arm | Type | Receives |
|---|---|---|
| laser, leg veins, sclerotherapy | Other | Procedure: 1064 Nd:YAG laserto compare laser and sclerotherapy on treating leg veins |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with leg telangiectasias
Key exclusion criteria (3 listed)
- varicose veins
- DVT
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1064 Nd:YAG laser1064 laser - 135J 25ms spot 3mm GLicose - 75% - 3 ml | Procedure or surgery | laser, leg veins, sclerotherapy |
Primary outcome
Changes analysis after treatments of leg telangiectasias´clearance through photography using a scale of improvement.
Time frame: Analysis of photographic changes previous, and one week after treatment. Patient reanalysis after 1 and 3 months
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
Time frame: 1 week after treatment
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
Time frame: 1 week after treatment
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
Time frame: 1 week after treatment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelson Wolosker, MD, PhD study director
Hospital das Clinicas, University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1064 Nd:YAG laser in people with Leg Veins, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes analysis after treatments of leg telangiectasias´clearance through photography using a scale of improvement. (time frame: Analysis of photographic changes previous, and one week after treatment. Patient reanalysis after 1 and 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.