Prolonged Compression Following Foam Sclerotherapy

NCT06766968 | Active Not Recruiting DMC

• 1 other identifier: ProCOMFFS
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Venous Disorder; Varicose Veins Leg

Keywords

varicose veins; chronic venous disease; sclerotherapy; medical compression stockings

Outcome Measures

Primary Outcomes (1)

• Number of patients with hyperpigmentation at 28 days

  Assessed by a blinded expert based on the analysis of photographic images of the legs in 4 projections (front, back, right, and left) as the presence of a linear area of skin in various shades of brown in the projection of sclerosed veins.

  28 days

Secondary Outcomes (20)

• Intensity of the hyperpigmentation at 28 days

  28 days

• Number of patients with hyperpigmentation at 6 months

  6 months

• Intensity of hyperpigmentation at 6 months

  6 months

• Intensity of spontaneous pain in the sclerosed vein at 28 days

  28 days

• Intensity of spontaneous pain in the sclerosed vein at 6 months

  6 months

Study Arms (2)

Group 1: MCS for 1 month

EXPERIMENTAL

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.

Device: Graduated Compression Stocking: 1 month using

Group 2: MCS for 1 week

ACTIVE COMPARATOR

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.

Device: Graduated Compression Stocking: 1 week using

Interventions

Graduated Compression Stocking: 1 week using 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

Graduated Compression Stocking: 1 month using DEVICE

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

Group 1: MCS for 1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

MedSwiss Private Clinic

Moscow, 123056, Russia

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kirill Lobastov, PhD

  Pirogov Russian National Research Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking Description
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A single-center, open, superiority randomized controlled trial with a blinded outcome assessor.

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 9, 2025
• Study Start: December 16, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After results publication indefinitely
• Access Criteria: By the personal request

Locations

RU (1)