Health TrialsbyHealthPanel

Laser Treatment of Reticular Leg Veins vs. Sclerotherapy

ConditionReticular Leg Veins
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorDerzhavin Tambov State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

women over 18

reticular veins

signed informed consent to participate in the study

Disqualifiers

diabetes mellitus

pregnancy or lactation

malignant neoplasms

inability or unwillingness of the patient to wear compression stockings

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laser ablation

    Procedure/Surgery

    Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, laser

  • Laser with Sclerotherapy

    Procedure/Surgery

    Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, laser plus sclerotherapy

  • Sclerotherapy

    Procedure/Surgery

    Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy

Treatment groups

174 Participants
are divided into 3 treatment groups
Group A: LaserActive comparator 1 intervention
Group B: Laser with SclerotherapyActive comparator 1 intervention
Group C: SclerotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Disappearance of the reticular vein

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.

Time frame
6 months

Secondary outcomes

1

Pain during the procedure: Numerical Rating Scale

Estimate of the pain on Numerical Rating Scale. Numerical Rating Scale \[NRS\] is a measure of pain intensity from 0 to 10 points.

Time frame
immediately after the procedure
2

Patient Satisfaction After Treatment

Assessment of patient satisfaction on the 3-point scale : no result (0 points), incomplete satisfaction (1 point), complete satisfaction (2 points)

Time frame
6 months
3

Intensity of hyperpigmentation

Assessment of Intensity of hyperpigmentation on Skin Hyperpigmentation Index (SHI)

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Derzhavin Tambov State University

Lead sponsor

Source ClinicalTrials.gov
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