Prolonged Compression Following Foam Sclerotherapy

NCT ID: NCT06766968

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-16
• Study Completion Date: 2026-07-31

Brief 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.

Detailed Description

Foam-form sclerotherapy effectively eliminates varicose veins, which can be used independently or combined with trunkal ablation to treat chronic venous disease. Sclerotherapy eliminates both primary and recurrent varicosity and is associated with a low frequency of complications. Among the adverse events, the most common is skin hyperpigmentation, with a 6-53% detection rate during the first month after the procedure. However, it resolves spontaneously in 70% of cases within a follow-up period of up to 6 months. Compression therapy is currently considered a mandatory component of sclerotherapy for telangiectasias and reticular veins. Studies indicate that its use for periods ranging from 3 days to 4 months can reduce the incidence of hyperpigmentation by 1.5 to 5 times.

Meanwhile, the role of elastic compression during foam-from sclerotherapy of varicose tributaries has not yet been fully clarified. According to a recent randomized controlled study CONFETTI, wearing medical compression stockings (MCS) with a pressure of 18-24 mm Hg at the ankle continuously for 7 days compared to applying a compression bandage for 24 hours was associated with a reduction in pain intensity. Still, it did not affect the severity of chronic venous disease, quality of life, time to return to normal activity, technical success of the procedure, or the frequency of bruising. However, the risk and severity of hyperpigmentation and other adverse effects were not investigated. Therefore, there is a need to determine the feasibility of prolonged use of MCS after foam-form sclerotherapy for varicose veins.

Conditions

Chronic Venous Disorder; Varicose Veins Leg

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Graduated Compression Stocking: 1 month using

Intervention Type: DEVICE

Class 2 (RAL-GZ 387 standard: 23-32 mm Hg at the ankle level) above-knee graduated compression stockings

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.

Group Type: ACTIVE_COMPARATOR

Graduated Compression Stocking: 1 week using

Intervention Type: DEVICE

Class 2 (RAL-GZ 387 standard: 23-32 mm Hg at the ankle level) above-knee graduated compression stockings

Interventions

Graduated Compression Stocking: 1 month using

Class 2 (RAL-GZ 387 standard: 23-32 mm Hg at the ankle level) above-knee graduated compression stockings

Intervention Type: DEVICE

Graduated Compression Stocking: 1 week using

Class 2 (RAL-GZ 387 standard: 23-32 mm Hg at the ankle level) above-knee graduated compression stockings

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• History of deep vein thrombosis;
• Contraindications or restrictions to foam-form sclerotherapy;
• Contraindications or restrictions to long-term use of compression therapy;
• Inability or difficulty in independently putting on MCS;
• Refusal to participate in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pirogov Russian National Research Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kirill Lobastov

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kirill Lobastov, PhD

Role: PRINCIPAL_INVESTIGATOR

Pirogov Russian National Research Medical University

Locations

MedSwiss Private Clinic

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Kirill Lobastov, PhD

Role: CONTACT

lobastov_kv@hotmail.com

+79852116331

Facility Contacts

Polina Serebryakova

Role: primary

polina.serebryakova.2014@mail.ru

+79150144843

Other Identifiers

ProCOMFFS

Identifier Type: -

Identifier Source: org_study_id