Clinical trial NCT06766968: Prolonged Compression Following Foam Sclerotherapy
Official title: Prolonged Compression Therapy Following Foam Sclerotherapy of Varicose Veins
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Venous Disorder
Varicose Veins Leg
Keywords: varicose veins
chronic venous disease
sclerotherapy
medical compression stockings
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-center, open, superiority randomized controlled trial with a blinded outcome assessor.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of patients with hyperpigmentation at 28 days
timeFrame: 28 days
Secondary outcomes:
measure: Intensity of the hyperpigmentation at 28 days
timeFrame: 28 days
measure: Number of patients with hyperpigmentation at 6 months
timeFrame: 6 months
measure: Intensity of hyperpigmentation at 6 months
timeFrame: 6 months
measure: Intensity of spontaneous pain in the sclerosed vein at 28 days
timeFrame: 28 days
measure: Intensity of spontaneous pain in the sclerosed vein at 6 months
timeFrame: 6 months
measure: Intensity of stimulated pain in the sclerosed vein at 28 days
timeFrame: 28 days
measure: Intensity of stimulated pain in the sclerosed vein at 6 months
timeFrame: 6 months
measure: Number of patients with resorption of sclerosed veins at 6 months
timeFrame: 6 months
measure: The value of VCSS at 28 days
timeFrame: 28 days
measure: The value of VCSS at 6 months
timeFrame: 6 months
measure: The value of CIVIQ-20 score at 28 days
timeFrame: 28 days
measure: The value of CIVIQ-20 score at 6 months
timeFrame: 6 months
measure: Level of comfort with the use of MCS at 7 days
timeFrame: 7 days
measure: Level of comfort with the use of MCS at 28 days
timeFrame: 28 days
measure: Compliance with the use of MCS
timeFrame: 28 days
measure: Difference in the interface pressure below the MCS
timeFrame: 28 days
measure: Number of patients with symptomatic venous thromboembolism
timeFrame: 6 months
measure: Number of patients with phlebitis of the sclerosed vein
timeFrame: 6 months
measure: Number of patients with skin lesions
timeFrame: 6 months
measure: Number of patients with adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: MedSwiss Private Clinic
Study officials:
affiliation: Pirogov Russian National Research Medical University
name: Kirill Lobastov, PhD
role: PRINCIPAL_INVESTIGATOR
References: