Reticular Leg VeinsNCT06175754
Laser Treatment of Reticular Leg Veins vs. Sclerotherapy
A study testing Laser ablation, Laser with Sclerotherapy and Sclerotherapy in people with Reticular Leg Veins, run by Derzhavin Tambov State University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Reticular Leg Veins
- What is being tested?
- Laser ablation, Laser with Sclerotherapy and Sclerotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteRussia
- Study dates
- 9 Oct 2023to 9 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women over 18
- reticular veins
- signed informed consent to participate in the study
Who cannot join
- 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,
Show all 10Show fewer
- known hereditary thrombophilia.
- period after treatment of alcoholism
- reception of oral contraceptives
- sedentary lifestyle
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Bukina Oksana Vasilyevna
Tambov, 392002
Oksana V Bukina, PhD, +79051204983, ovsafonova@yandex.ru
Gusen I Kurbanov, +79622348861, alpha297@mail.ru
About this study
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.
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.
Read the 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.
- Conditions
- Reticular Leg Veins
- Being tested
- Laser ablation, Laser with Sclerotherapy, Sclerotherapy
- Keywords
- reticular veins, long-pulsed Nd:YAG laser, sclerotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser ablationProcedure or surgery
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, laser
Laser with SclerotherapyProcedure or surgery
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, laser plus sclerotherapy
SclerotherapyProcedure or surgery
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Procedure: Sclerotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 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)
Measured: 6 months
Intensity of hyperpigmentation
Assessment of Intensity of hyperpigmentation on Skin Hyperpigmentation Index (SHI)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start9 Oct 2023
- Primary completion9 Jul 2025 (estimated)
- Study completion9 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Reticular Leg VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Derzhavin Tambov State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oksana Bukina, Derzhavin Tambov State University
- Investigators
- Oksana V Bukina, PhD, Principal investigator, Derzhavin Tambov State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175754
- Sponsor's protocol ID
- DerzhavinTambovSU
- Status last verified
- Dec 2024
- First submitted
- 7 Oct 2023
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study data are available to all investigators in the chronic vein disease registry
Publications
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.
PubMed 35691663Georgiev 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.
PubMed 2362024Goldman 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.
PubMed 7600016Parlar 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.
PubMed 25069999Ianosi 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.
PubMed 30679981Ozden 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.
PubMed 20666669Rogachefsky 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.
PubMed 11896772Sadick 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.
PubMed 12930332Moreno-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.
PubMed 23989971Fonseca 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.
PubMed 36657386
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06175754
- Acronym / sponsor ID
- DerzhavinTambovSU
- Conditions
- Reticular Leg Veins
- Keywords
- reticular veins, long-pulsed Nd:YAG laser, sclerotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Derzhavin Tambov State UniversityUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 9 Jul 2025 (estimated)
- Study completion
- 9 Dec 2025 (estimated)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laser | Active comparator | Procedure: Laser ablationto 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 | Active comparator | Procedure: Laser with Sclerotherapyto 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. |
| Sclerotherapy | Active comparator | Procedure: Sclerotherapyto 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women over 18
- reticular veins
- signed informed consent to participate in the study
Key exclusion criteria (10 listed)
- diabetes mellitus
- pregnancy or lactation
- malignant neoplasms
- inability or unwillingness of the patient to wear compression stockings
- hypersensitivity to the polidocanol, cold, sunlight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser ablationExamination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, laser | Procedure or surgery | Laser |
| Laser with SclerotherapyExamination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, laser plus sclerotherapy | Procedure or surgery | Laser with Sclerotherapy |
| SclerotherapyExamination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy | Procedure or surgery | Sclerotherapy |
Primary outcome
Disappearance of the reticular vein
Time frame: 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.
3 secondary outcomes
Pain during the procedure: Numerical Rating Scale
Time frame: immediately after the procedure
Patient Satisfaction After Treatment
Time frame: 6 months
Intensity of hyperpigmentation
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Results publication: PubMed 35691663Nyamekye 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.
- Results publication: PubMed 2362024Georgiev 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.
- Results publication: PubMed 7600016Goldman 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.
- Results publication: PubMed 25069999Parlar 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.
- Results publication: PubMed 30679981Ianosi 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.
- Results publication: PubMed 20666669Ozden 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.
- Results publication: PubMed 11896772Rogachefsky 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.
- Results publication: PubMed 12930332Sadick 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.
- Results publication: PubMed 23989971Moreno-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.
- Results publication: PubMed 36657386Fonseca 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.
- Individual participant dataSharing planned: Yes. The study data are available to all investigators in the chronic vein disease registry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oksana V Bukina, PhD principal investigator
Derzhavin Tambov State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser ablation, Laser with Sclerotherapy and Sclerotherapy in people with Reticular Leg Veins, run by Derzhavin Tambov State University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oksana V Bukina, PhD (+79051204983, ovsafonova@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disappearance of the reticular vein (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06175754, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.