Laser Treatment of Reticular Leg Veins Vs. Sclerotherapy
- Conditions
- Reticular Leg Veins
- Interventions
- Procedure: SclerotherapyProcedure: Laser ablationProcedure: Laser with Sclerotherapy
- Registration Number
- NCT06175754
- Lead Sponsor
- Derzhavin Tambov State University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 174
- women over 18
- reticular veins
- signed informed consent to participate in the study
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sclerotherapy 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. Laser 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 50 msec and fluency 140 J/cm2 Laser with Sclerotherapy 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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)
Trial Locations
- Locations (1)
Bukina Oksana Vasilyevna
🇷🇺Tambov, Russian Federation