An interventional study of Sclerotherapy in Sclerotherapy, sponsored by Derzhavin Tambov State University. Completed at 1 site in Russian Federation. Open to female participants. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Derzhavin Tambov State University · Not applicable, Interventional, and Treatment
Using of low concentrate sodium tetradecyl sulfate for sclerotherapy of telangiectasias should be no less effective than hypertonic glucose, and have a comparable frequency of adverse events.
For sclerotherapy of telangiectasias are used detergents. These are aggressive substances, which have a high frequency of adverse events. According to histological studies the safest concentration for the treatment of telangiectasias is less than that specified in the official instructions. The concentration of sodium tetradecyl sulfate 0.15% was effective and did not cause any adverse reactions in the treatment of telangiectasias from 0.8 to 1 mm in diameter. Small telangiectases (0.5 mm or less) require the treatment with the less aggressive sclerosing agent. Perhaps, the sodium tetradecyl sulfate 0.15%, 0.1% or even 0.05% and hypertonic glucose may be more effective and safe in this situation.
Derzhavin Tambov State University is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* to take photo of problem area in the patient's standing position in the room with artificial lighting using the iPhone 6s and above, Samsung Galaxy S7 and above from a distance of 20 cm. * to measure the maximum diameter of telangiectasia using the Dermatoscope scale. * to inject the 75% glucose, with a 2 ml luer-lock syringe through 30 G needle in telangiectasia until the vessel disappears.
Procedure: Sclerotherapy
* to take photo of problem area in the patient's standing position in the room with artificial lighting using the iPhone 6s and above, Samsung Galaxy S7 and above from a distance of 20 cm. * to measure the maximum diameter of telangiectasia using the Dermatoscope scale. * to inject the 0.05% sodium tetradecyl sulfate with a 2 ml luer-lock syringe through 30 G needle in telangiectasia until the vessel disappears.
Procedure: Sclerotherapy
* to take photo of problem area in the patient's standing position in the room with artificial lighting using the iPhone 6s and above, Samsung Galaxy S7 and above from a distance of 20 cm. * to measure the maximum diameter of telangiectasia using the Dermatoscope scale. * to inject the 0.1% sodium tetradecyl sulfate with a 2 ml luer-lock syringe through 30 G needle in telangiectasia until the vessel disappears.
Procedure: Sclerotherapy
* to take photo of problem area in the patient's standing position in the room with artificial lighting using the iPhone 6s and above, Samsung Galaxy S7 and above from a distance of 20 cm. * to measure the maximum diameter of telangiectasia using the Dermatoscope scale. * to inject the 0.15% sodium tetradecyl sulfate with a 2 ml luer-lock syringe through 30 G needle in telangiectasia until the vessel disappears.
Procedure: Sclerotherapy
Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy according to the randomization group
Disappearance of the telangiectasia
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.
Time frame: 2 months
Pain during the procedure: visual analog scale
Estimate of the pain on visual analog scale. Visual analog scale \[VAS\] is a measure of pain intensity. It is a continuous scale comprised of a horizontal 10 cm length: "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).
Time frame: 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)
Time frame: 2 months
Plan to share: Yes — The study data are available to all investigators in the chronic vein disease registry.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: From 25 October 2019 to 25 December 2021
Data sharing details ↗ · www.venousregistry.org
Ran from Oct 2019 to primary completion in Mar 2022, 28 months.
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Derzhavin Tambov State University