Prolonged Compression Following Foam Sclerotherapy (ProCOMFFS)

Pirogov Russian National Research Medical University

Status: Enrolling

Conditions: Varicose Veins Leg; Chronic Venous Disorder

Treatments: Device: Graduated Compression Stocking: 1 week using; Device: Graduated Compression Stocking: 1 month using

Study type: Interventional

Funder types: Other

Identifiers

NCT06766968

ProCOMFFS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18 years;
• Varicose veins of the lower extremities of clinical class C2 according to CEAP 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

140 participants in 2 patient groups

Group 1: MCS for 1 month

Experimental group

Description:

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.

Treatment:

Device: Graduated Compression Stocking: 1 month using

Group 2: MCS for 1 week

Active Comparator group

Description:

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.

Treatment:

Device: Graduated Compression Stocking: 1 week using