NCT06766968

Prolonged Compression Following Foam Sclerotherapy

Prolonged Compression Therapy Following Foam Sclerotherapy of Varicose Veins

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Pirogov Russian National Research Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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
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

Timeline

• Start date: 2024-12-16
• Primary completion: 2025-12-31
• Completion: 2026-07-31
• First posted: 2025-01-09
• Last updated: 2026-03-02

Locations

1 site across 1 country: Russia