Clinical trial NCT06175754: Laser Treatment of Reticular Leg Veins Vs. Sclerotherapy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Reticular Leg Veins
Keywords: reticular veins
long-pulsed Nd:YAG laser
sclerotherapy
Lead sponsor: Derzhavin Tambov State University
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 174
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disappearance of the reticular vein
timeFrame: 6 months
Secondary outcomes:
measure: Pain during the procedure: Numerical Rating Scale
timeFrame: immediately after the procedure
measure: Patient Satisfaction After Treatment
timeFrame: 6 months
measure: Intensity of hyperpigmentation
timeFrame: 6 months
Other outcomes:
Locations:
city: Tambov
country: Russian Federation
facility: Bukina Oksana Vasilyevna
Study officials:
affiliation: Derzhavin Tambov State University
name: Oksana V Bukina, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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