Prolonged Compression Therapy Following Foam Sclerotherapy of Varicose Veins

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Foam-form sclerotherapy is an effective method for eliminating varicose veins, which can be used alone or in combination with other interventions (laser or radiofrequency ablation, cyanoacrylate glue embolization) in the treatment of chronic venous disease of the lower limbs. Sclerotherapy is utilized to address both primary and recurrent varicose veins, and it is associated with a low rate of complications. Among the adverse effects, the most common is skin hyperpigmentation (darkening of the skin with the formation of stripes of shades of brown directly above the treated veins), with an occurrence rate reaching 6-53% within the first month following the procedure. Still, it resolves independently in 70% of cases within 6 months. An essential component of sclerotherapy is compression therapy through bandages or medical stockings, which helps accelerate the absorption of veins and improve the aesthetic results of treatment. Meanwhile, the optimal duration for wearing compression stockings after performing foam-form sclerotherapy of varicose tributaries has not been established.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age over 18 years;

• Varicose veins of the lower extremities of clinical class C2 according to CEAP (Clinical, Etiological, Anatomical, Pathophysiological) classification;

• Scheduled foam-form sclerotherapy of varicose tributaries as an independent intervention or after trunkal ablation;

• Absence of initial skin pigmentation, including that associated with previously performed trunk ablation;

• Absence of indications for long-term use of compression therapy, including the clinical class of chronic venous disease C3-C6 and persistence of vein-specific symptoms;

• Signed informed consent to participate in the study.

Locations
Other Locations
Russian Federation
MedSwiss Private Clinic
RECRUITING
Moscow
Contact Information
Primary
Kirill Lobastov, PhD
lobastov_kv@hotmail.com
+79852116331
Time Frame
Start Date: 2024-12-16
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 140
Treatments
Experimental: Group 1: MCS for 1 month
The patient will be prescribed to use medical compression stockings (MCS of class 2 of RAL GZ 387 standard with a pressure of 23-32 mm Hf at the ankle) continuously for 7 days between the sessions and after the last session of foam-form sclerotherapy. After that, he should continue wearing the MCS during the day (put it on within 30 minutes after getting out of bed, remove it within 30 minutes before going to sleep, and wear it for at least 12 hours a day) for 28 days.
Active_comparator: Group 2: MCS for 1 week
The patient will be prescribed to use medical compression stockings (MCS of class 2 of RAL GZ 387 standard with a pressure of 23-32 mm Hf at the ankle) continuously for 7 days between the sessions and after the last session of foam-form sclerotherapy. After that he will stop using MCS.
Related Therapeutic Areas
Sponsors
Leads: Pirogov Russian National Research Medical University

This content was sourced from clinicaltrials.gov