An interventional study of Laser ablation and Laser with Sclerotherapy in Reticular Leg Veins, sponsored by Derzhavin Tambov State University. Recruiting at 1 site in Russian Federation. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Derzhavin Tambov State University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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
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, laser
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, laser plus sclerotherapy
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy
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
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
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
Intensity of hyperpigmentation
Assessment of Intensity of hyperpigmentation on Skin Hyperpigmentation Index (SHI)
Time frame: 6 months
Plan to share: Yes — The study data are available to all investigators in the chronic vein disease registry
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Derzhavin Tambov State University