Chronic Venous DisorderProCOMFFSNCT06766968
Prolonged Compression Following Foam Sclerotherapy
A study testing Graduated Compression Stocking: 1 month using and Graduated Compression Stocking: 1 week using in people with Chronic Venous Disorder and Varicose Veins Leg, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Disorder, Varicose Veins Leg
- What is being tested?
- Graduated Compression Stocking: 1 month using and Graduated Compression Stocking: 1 week using
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteRussia
- Study dates
- 16 Dec 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Prolonged Compression Therapy Following Foam Sclerotherapy of Varicose Veins
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.
Read the 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
- Being tested
- Graduated Compression Stocking: 1 month using, Graduated Compression Stocking: 1 week using
- Keywords
- varicose veins, chronic venous disease, sclerotherapy, medical compression stockings
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graduated Compression Stocking: 1 month usingDevice
Class 2 (RAL-GZ 387 standard: 23-32 mm Hg at the ankle level) above-knee graduated compression stockings
Graduated Compression Stocking: 1 week usingDevice
Class 2 (RAL-GZ 387 standard: 23-32 mm Hg at the ankle level) above-knee graduated compression stockings
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Graduated Compression Stocking: 1 week using |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (20)
Intensity of the hyperpigmentation at 28 days
Assessed by a blinded expert based on the analysis of photographic images of the legs in four projections (front, back, right, and left) using a 4-level Likert's-like scale: 0 - no pigmentation, 1 - mild hyperpigmentation, 2 - moderate hyperpigmentation, 3 - severe hyperpigmentation.
Measured: 28 days
Number of patients with hyperpigmentation at 6 months
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.
Measured: 6 months
Intensity of hyperpigmentation at 6 months
Assessed by a blinded expert based on the analysis of photographic images of the legs in four projections (front, back, right, and left) using a 4-level Likert's-like scale: 0 - no pigmentation, 1 - mild hyperpigmentation, 2 - moderate hyperpigmentation, 3 - severe hyperpigmentation.
Measured: 6 months
Intensity of spontaneous pain in the sclerosed vein at 28 days
The intensity of pain over the sclerosed vein is assessed subjectively by the patient on a 10-cm numeric rating scale at rest. Ranges from 0 (no pain) to 10 (pain of the maximal intensity).
Measured: 28 days
Intensity of spontaneous pain in the sclerosed vein at 6 months
The intensity of pain over the sclerosed vein is assessed subjectively by the patient on a 10-cm numeric rating scale at rest. Ranges from 0 (no pain) to 10 (pain of the maximal intensity).
Measured: 6 months
Intensity of stimulated pain in the sclerosed vein at 28 days
The intensity of pain over the sclerosed vein is assessed subjectively by the patient on a 10-cm numeric rating scale during compression of the vein. Ranges from 0 (no pain) to 10 (pain of the maximal intensity).
Measured: 28 days
Intensity of stimulated pain in the sclerosed vein at 6 months
The intensity of pain over the sclerosed vein is assessed subjectively by the patient on a 10-cm numeric rating scale during compression of the vein. Ranges from 0 (no pain) to 10 (pain of the maximal intensity).
Measured: 6 months
Number of patients with resorption of sclerosed veins at 6 months
The absence of any signs of previously obliterated veins (visible veins, thickened areas) upon examination and palpation by the Investigator.
Measured: 6 months
The value of VCSS at 28 days
The severity of chronic venous disease (CVD) in the target lower limb is assessed during clinical examination using the updated Venous Clinical Severity Score (VCSS). Ranges from 0 to 30. The maximal score indicates more severe CVD.
Measured: 28 days
The value of VCSS at 6 months
The severity of chronic venous disease (CVD) in the target lower limb is assessed during clinical examination using the updated Venous Clinical Severity Score (VCSS). Ranges from 0 to 30. The maximal score indicates more severe CVD.
Measured: 6 months
The value of CIVIQ-20 score at 28 days
The quality of life is assessed by the patient independently according to the vein-specific questionnaire Chronic Lower Limb Venous Insufficiency Questionnaire - 20 items (CIVIQ-20). range 0-100, a minimal score indicates the best quality of life.
Measured: 28 days
The value of CIVIQ-20 score at 6 months
The quality of life is assessed by the patient independently according to the vein-specific questionnaire Chronic Lower Limb Venous Insufficiency Questionnaire - 20 items (CIVIQ-20). range 0-100, a minimal score indicates the best quality of life.
Measured: 6 months
Level of comfort with the use of MCS at 7 days
The patients subjectively assess their comfort when using MCS using a 10-cm numeric rating scale, which ranges from 0 (no comfort) to 10 (absolute comfort).
Measured: 7 days
Level of comfort with the use of MCS at 28 days
The patients of Group 1 (Experimental) subjectively assess their comfort when using MCS using a 10-cm numeric rating scale, which ranges from 0 (no comfort) to 10 (absolute comfort).
Measured: 28 days
Compliance with the use of MCS
Compliance with the use of MCS is assessed based on the study of the patient's diaries in Group 1 (Experimental) as a proportion of the number of days when the patient used MCS for at least 12 hours to the total duration of prescribed compression (28 days) represented as a percentage (n[MCS]/28*100%). It ranges from 0% (no compliance) to 100% (absolute compliance).
Measured: 28 days
Difference in the interface pressure below the MCS
The level of interface pressure under the MCS is measured in real-time using the "PicoPress" manometer ("Microlab", Italy) at points B (ankle), B1 (midway between B and C), C (widest part of the calf), D (head of the fibula), F (mid-thigh), and G (upper third of the thigh) in mm Hg. The measurements are performed in Group 1 (Experimental) at the randomization before the first application of the stocking (day 0) and on day 28. The difference is reported as the pressure at the B1 point on day 0 minus pressure at the B1 point on day 28 (pressure B1[d0] - pressure B1[d28]. It may range in a broad spectrum of numbers from 0 (no changes in the pressure over time) to minus figures (pressure increases over time) or plus figures (pressure decreases over time). It is assumed that the range should be between -10 and +10 mm Hg.
Measured: 28 days
Number of patients with symptomatic venous thromboembolism
Symptomatic venous thromboembolism includes deep vein thrombosis, pulmonary embolism, and superficial vein thrombosis of the vein not previously treated with foam-form sclerotherapy confirmed by appropriate medical imaging (duplex ultrasound, CT-pulmonary angiography).
Measured: 6 months
Number of patients with phlebitis of the sclerosed vein
Phlebitis of a sclerosed vein refers to the appearance of signs of inflammation (hyperemia, swelling, pain) in the projection of a previously treated with foam sclerotherapy vein.
Measured: 6 months
Number of patients with skin lesions
Skin lesions related to the use of MCS refer to the emergence of dryness, peeling, rashes, hyperemia, swelling, weeping, and breaches in skin integrity while wearing compression stockings.
Measured: 6 months
Number of patients with adverse events
Refers to any other adverse events despite skin lesions that could be associated with using MCS of foaf-form sclerotherapy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start16 Dec 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, open, superiority randomized controlled trial with a blinded outcome assessor.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirill Lobastov, Pirogov Russian National Research Medical University
- Investigators
- Kirill Lobastov, PhD, Principal investigator, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766968
- Sponsor's protocol ID
- ProCOMFFS
- Acronym
- ProCOMFFS
- Status last verified
- Sep 2026
- First submitted
- 4 Jan 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: By the personal request
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Compression Therapy Following Foam Sclerotherapy of Varicose Veins
- ClinicalTrials.gov ID
- NCT06766968
- Acronym / sponsor ID
- ProCOMFFS / ProCOMFFS
- Conditions
- Chronic Venous Disorder, Varicose Veins Leg
- Keywords
- varicose veins, chronic venous disease, sclerotherapy, medical compression stockings
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single-center, open, superiority randomized controlled trial with a blinded outcome assessor.
| Arm | Type | Receives |
|---|---|---|
| Group 1: MCS for 1 month | Experimental | Device: Graduated Compression Stocking: 1 month usingThe 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 2: MCS for 1 week | Active comparator | Device: Graduated Compression Stocking: 1 week usingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graduated Compression Stocking: 1 month usingClass 2 (RAL-GZ 387 standard: 23-32 mm Hg at the ankle level) above-knee graduated compression stockings | Device | Group 1: MCS for 1 month |
| Graduated Compression Stocking: 1 week usingClass 2 (RAL-GZ 387 standard: 23-32 mm Hg at the ankle level) above-knee graduated compression stockings | Device | Group 2: MCS for 1 week |
Primary outcome
Number of patients with hyperpigmentation at 28 days
Time frame: 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.
20 secondary outcomes
Intensity of the hyperpigmentation at 28 days
Time frame: 28 days
Number of patients with hyperpigmentation at 6 months
Time frame: 6 months
Intensity of hyperpigmentation at 6 months
Time frame: 6 months
Intensity of spontaneous pain in the sclerosed vein at 28 days
Time frame: 28 days
Intensity of spontaneous pain in the sclerosed vein at 6 months
Time frame: 6 months
Intensity of stimulated pain in the sclerosed vein at 28 days
Time frame: 28 days
Intensity of stimulated pain in the sclerosed vein at 6 months
Time frame: 6 months
Number of patients with resorption of sclerosed veins at 6 months
Time frame: 6 months
The value of VCSS at 28 days
Time frame: 28 days
The value of VCSS at 6 months
Time frame: 6 months
The value of CIVIQ-20 score at 28 days
Time frame: 28 days
The value of CIVIQ-20 score at 6 months
Time frame: 6 months
Level of comfort with the use of MCS at 7 days
Time frame: 7 days
Level of comfort with the use of MCS at 28 days
Time frame: 28 days
Compliance with the use of MCS
Time frame: 28 days
Difference in the interface pressure below the MCS
Time frame: 28 days
Number of patients with symptomatic venous thromboembolism
Time frame: 6 months
Number of patients with phlebitis of the sclerosed vein
Time frame: 6 months
Number of patients with skin lesions
Time frame: 6 months
Number of patients with adverse events
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes. By the personal request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirill Lobastov, PhD principal investigator
Pirogov Russian National Research Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graduated Compression Stocking: 1 month using and Graduated Compression Stocking: 1 week using in people with Chronic Venous Disorder and Varicose Veins Leg, run by Pirogov Russian National Research Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with hyperpigmentation at 28 days (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.