Reticular Leg Veins
Conditions
Keywords
reticular veins, long-pulsed Nd:YAG laser, sclerotherapy
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.
Interventions
PROCEDURELaser ablation
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, laser
PROCEDURELaser with Sclerotherapy
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, laser plus sclerotherapy
PROCEDURESclerotherapy
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy
Sponsors
Derzhavin Tambov State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disappearance of the reticular vein | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction After Treatment | 6 months | Assessment of patient satisfaction on the 3-point scale : no result (0 points), incomplete satisfaction (1 point), complete satisfaction (2 points) |
| Intensity of hyperpigmentation | 6 months | Assessment of Intensity of hyperpigmentation on Skin Hyperpigmentation Index (SHI) |
| Pain during the procedure: Numerical Rating Scale | 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. |
Countries
Russia
Contacts
Primary ContactOksana V Bukina, PhD
Backup ContactGusen I Kurbanov
Outcome results
None listed