Laser Treatment of Reticular Leg Veins Vs. Sclerotherapy

NCT06175754 | Recruiting

• 1 other identifier: DerzhavinTambovSU
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Reticular Leg Veins

Keywords

reticular veins; long-pulsed Nd:YAG laser; sclerotherapy

Outcome Measures

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.

  6 months

Secondary Outcomes (3)

• Pain during the procedure: Numerical Rating Scale

  immediately after the procedure

• Patient Satisfaction After Treatment

  6 months

• Intensity of hyperpigmentation

  6 months

Study Arms (3)

Laser

ACTIVE COMPARATOR

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

Laser with Sclerotherapy

ACTIVE COMPARATOR

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

Sclerotherapy

ACTIVE COMPARATOR

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

Interventions

Laser ablation PROCEDURE

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

Laser

Laser with Sclerotherapy PROCEDURE

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

Laser with Sclerotherapy

Sclerotherapy PROCEDURE

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

Sclerotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women over 18
• reticular veins
• signed informed consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Derzhavin Tambov State University: lead

Study Sites (1)

Bukina Oksana Vasilyevna

Tambov, 392002, Russia

RECRUITING

Related Publications (10)

• Nyamekye IK. European Society for Vascular Surgery (ESVS) 2022 clinical practice guidelines on the management of chronic venous disease of the lower limbs. J Med Vasc. 2022 Apr;47(2):53-55. doi: 10.1016/j.jdmv.2022.04.003. Epub 2022 May 23. No abstract available.

  PMID: 35691663 BACKGROUND

• Georgiev M. Postsclerotherapy hyperpigmentations: a one-year follow-up. J Dermatol Surg Oncol. 1990 Jul;16(7):608-10. doi: 10.1111/j.1524-4725.1990.tb00088.x.

  PMID: 2362024 BACKGROUND

• Goldman MP, Sadick NS, Weiss RA. Cutaneous necrosis, telangiectatic matting, and hyperpigmentation following sclerotherapy. Etiology, prevention, and treatment. Dermatol Surg. 1995 Jan;21(1):19-29; quiz 31-2. doi: 10.1111/j.1524-4725.1995.tb00107.x.

  PMID: 7600016 BACKGROUND

• Parlar B, Blazek C, Cazzaniga S, Naldi L, Kloetgen HW, Borradori L, Buettiker U. Treatment of lower extremity telangiectasias in women by foam sclerotherapy vs. Nd:YAG laser: a prospective, comparative, randomized, open-label trial. J Eur Acad Dermatol Venereol. 2015 Mar;29(3):549-54. doi: 10.1111/jdv.12627. Epub 2014 Jul 28.

  PMID: 25069999 BACKGROUND

• Ianosi G, Ianosi S, Calbureanu-Popescu MX, Tutunaru C, Calina D, Neagoe D. Comparative study in leg telangiectasias treatment with Nd:YAG laser and sclerotherapy. Exp Ther Med. 2019 Feb;17(2):1106-1112. doi: 10.3892/etm.2018.6985. Epub 2018 Nov 16.

  PMID: 30679981 BACKGROUND

• Ozden MG, Bahcivan M, Aydin F, Senturk N, Bek Y, Canturk T, Turanli AY. Clinical comparison of potassium-titanyl-phosphate (KTP) versus neodymium:YAG (Nd:YAG) laser treatment for lower extremity telangiectases. J Dermatolog Treat. 2011 Jun;22(3):162-6. doi: 10.3109/09546631003649679. Epub 2010 Jul 28.

  PMID: 20666669 BACKGROUND

• Rogachefsky AS, Silapunt S, Goldberg DJ. Nd:YAG laser (1064 nm) irradiation for lower extremity telangiectases and small reticular veins: efficacy as measured by vessel color and size. Dermatol Surg. 2002 Mar;28(3):220-3. doi: 10.1046/j.1524-4725.2002.01141.x.

  PMID: 11896772 BACKGROUND

• Sadick NS. Laser treatment with a 1064-nm laser for lower extremity class I-III veins employing variable spots and pulse width parameters. Dermatol Surg. 2003 Sep;29(9):916-9. doi: 10.1046/j.1524-4725.2003.29250.x.

  PMID: 12930332 BACKGROUND

• Moreno-Moraga J, Smarandache A, Pascu ML, Royo J, Trelles MA. 1064 nm Nd:YAG long pulse laser after polidocanol microfoam injection dramatically improves the result of leg vein treatment: a randomized controlled trial on 517 legs with a three-year follow-up. Phlebology. 2014 Dec;29(10):658-66. doi: 10.1177/0268355513502786. Epub 2013 Aug 29.

  PMID: 23989971 BACKGROUND

• Fonseca MM, Mocelin FJ, Grill MH, Gianesini S, Miyake K, Argenta R, Pereira AH. Nd:Yag laser combined with injection sclerotherapy in the treatment of reticular veins and telangiectasias (CLaCS method): A triple-blind randomized clinical trial comparing two sclerosing agents associated with same laser patterns. Phlebology. 2023 Apr;38(3):165-171. doi: 10.1177/02683555231153533. Epub 2023 Jan 19.

  PMID: 36657386 BACKGROUND

MeSH Terms

Interventions

Laser Therapy; Lasers; Sclerotherapy

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Drug Therapy

Study Officials

• Oksana V Bukina, PhD

  Derzhavin Tambov State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oksana V Bukina, PhD

CONTACT

+79051204983; ovsafonova@yandex.ru

Gusen I Kurbanov

CONTACT

+79622348861; alpha297@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research

Study Record Dates

• First Submitted: October 7, 2023
• First Posted: December 19, 2023
• Study Start: October 9, 2023
• Primary Completion: July 9, 2025
• Study Completion: December 9, 2025
• Last Updated: February 5, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From 09 October 2023 to 09 December 2024
• Access Criteria: RRT\ CVD 1.015

Locations

RU (1)