Laser Treatment of Reticular Leg Veins vs. Sclerotherapy

December 16, 2023 updated by: Oksana Bukina, Derzhavin Tambov State University

Treatment of Reticular Leg Veins: a Prospective, Randomized, Comparative Clinical Trial of a 1064 nm Nd:YAG Long Pulse Laser, Combined Treatment of a 1064 nm Nd:YAG Long Pulse Laser and Sclerotherapy vs. Sclerotherapy Alone.

Treatment of reticular veins with a 1064 nm long-pulsed Nd:YAG laser and combination of a 1064 nm Nd:YAG long pulse laser and sclerotherapy should be no less effective than sclerotherapy alone, and have a frequency of adverse events less then sclerotherapy alone.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Reticular leg veins are mostly an aesthetic problem. Sclerotherapy is considered the gold standard for treatment them. However, this method has a high frequency of long persistent hyperpigmentation which decreases the patients' satisfaction. It is a reason to find another method of treatment. Another possible technique to treat reticular veins is the Nd:YAG long pulse 1064 nm transdermal laser or Nd:YAG laser combined with injection sclerotherapy. There are a few studies comparing sclerotherapy with laser treatment and combined treatment with sclerotherapy. But there are no prospective, randomized, comparative clinical trials of all three methods: the 1064 nm Nd:YAG long pulse laser, combined treatment of a 1064 nm Nd:YAG long pulse laser with sclerotherapy and sclerotherapy alone. The aim of current study is the efficacy assessment of the 1064 nm long-pulsed Nd:YAG laser, combined treatment of the 1064 nm Nd:YAG long pulse laser with sclerotherapy and sclerotherapy alone for the treatment of reticular leg veins and analysis of side effects to establish advantages and disadvantage of these methods and find the best option for treatment of reticular leg veins.

Study Type

Interventional

Enrollment (Estimated)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • women over 18
  • reticular veins
  • signed informed consent to participate in the study

Exclusion Criteria:

  • diabetes mellitus
  • pregnancy or lactation
  • malignant neoplasms
  • inability or unwillingness of the patient to wear compression stockings
  • hypersensitivity to the polidocanol, cold, sunlight
  • concomitant diseases: bronchial asthma, severe liver and kidney disease, acute thrombosis and thrombophlebitis, infection of the skin and/or soft tissues, infectious diseases, arteriosclerosis, diabetic angiopathy, heart defects requiring surgery, fever, toxic hyperthyroidism, obesity, tuberculosis, sepsis, violation of the cellular composition of the blood, all diseases requiring bed rest, heart disease with decompensation phenomena,
  • known hereditary thrombophilia.
  • period after treatment of alcoholism
  • reception of oral contraceptives
  • sedentary lifestyle

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laser

to take photo of problem area in the patient's standing position in the room with artificial lighting using the Canon SX510 HS from a distance of 50 cm.

to measure the maximum diameter of telangiectasia using the Ultrasound Mindray M7 .

to treat the reticular vein by the Nd:YAG laser with a wavelength of 1064 nm, a 7 mm spot, pulse length of 50 msec and fluency 140 J/cm2
Procedure: Laser ablation
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, laser
Active Comparator: Laser with Sclerotherapy

to take photo of problem area in the patient's standing position in the room with artificial lighting using the Canon SX510 HS from a distance of 50 cm.

to measure the maximum diameter of telangiectasia using the Ultrasound Mindray M7 .

to treat the reticular vein by the Nd:YAG laser with a wavelength of 1064 nm, a 7 mm spot, pulse length of 15 msec and fluency 70 J/cm2 to inject the 0.3% foam polidocanol with a 5 ml luer-lock syringe through 30 G needle into reticular vein until the vessel disappears.
Procedure: Laser with Sclerotherapy
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, laser plus sclerotherapy
Active Comparator: Sclerotherapy

to take photo of problem area in the patient's standing position in the room with artificial lighting using the Canon SX510 HS from a distance of 50 cm.

to measure the maximum diameter of telangiectasia using the Ultrasound Mindray M7 .

to inject the 0.5% foam polidocanol with a 5 ml luer-lock syringe through 30 G needle into reticular vein until the vessel disappears.
Procedure: Sclerotherapy
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disappearance of the reticular vein
Time Frame: 6 months
The clearing of the vessels on the six-point scale (from 0 to 5 points): 5 - total disappearance of the matting (100% efficacy), 4 - disappearance of around 80%, 3 - disappearance of around 60%, 2 - disappearance of around 40%, 1 - disappearance of around 20%, 0 - no changes.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during the procedure: Numerical Rating Scale
Time Frame: immediately after the procedure
Estimate of the pain on Numerical Rating Scale. Numerical Rating Scale [NRS] is a measure of pain intensity from 0 to 10 points.
immediately after the procedure
Patient Satisfaction After Treatment
Time Frame: 6 months

Assessment of patient satisfaction on the 3-point scale :

no result (0 points), incomplete satisfaction (1 point), complete satisfaction (2 points)
6 months
Intensity of hyperpigmentation
Time Frame: 6 months
Assessment of Intensity of hyperpigmentation on Skin Hyperpigmentation Index (SHI)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Derzhavin Tambov State University

Investigators

  • Principal Investigator: Oksana V Bukina, PhD, Derzhavin Tambov State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2023

Primary Completion (Estimated)

December 9, 2024

Study Completion (Estimated)

December 9, 2024

Study Registration Dates

First Submitted

October 7, 2023

First Submitted That Met QC Criteria

December 16, 2023

First Posted (Estimated)

December 19, 2023

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 16, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DerzhavinTambovSU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study data are available to all investigators in the chronic vein disease registry

IPD Sharing Time Frame

From 09 October 2023 to 09 December 2024

IPD Sharing Access Criteria

RRT_CVD 1.015

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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