Varicose VeinsFISCHERNCT06913764
First- or Second- Class Compression Hosiery After Endovenous Laser With Sclerotherapy and Ambulatory Phlebectomy
A study testing class I compression stockings of the RAL-GZ 387 standard: 1 month using and class II compression stockings of the RAL-GZ 387 standard: 1 month using in people with Varicose Veins and Chronic Venous Disorder, run by Moscow City Hospital named after A.K. Eramishantsev at 1 site in Russia.
Trial summary
Investigators hypothesize that first class compression therapy during the postoperative period will improve patient adherence due to easier application and reduced discomfort. Therefore, planning to compare the effectiveness of fist class versus second class compression therapy two weeks after EVLA of the great… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins, Chronic Venous Disorder, Chronic Venous Insufficiency (CVI)
- What is being tested?
- class I compression stockings of the RAL-GZ 387 standard: 1 month using and class II compression stockings of the RAL-GZ 387 standard: 1 month using
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 7 Apr 2025to 2 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 ≥18 years
- Varicose veins of the lower extremities (CEAP classification C2-C5)
- Varicose disease in the great saphenous vein (GSV) and its tributaries
- Planned endovenous laser ablation of the GSV trunk with concomitant combined sclerotherapy and phlebectomy of tributaries
- Technical success of intervention (complete ablation of the GSV)
- Signed informed consent for study participation
Who cannot join
- Primary reflux outside the GSV trunk
- History of or acute deep vein thrombosis
- Deep vein insufficiency
- GSV recanalization post-intervention
- Clinical class C6 of chronic venous disease (CVD) according to CEAP classification
- Contraindications or limitations for prolonged compression therapy, including but not limited to chronic arterial diseases of the lower extremities (any severity), skin diseases
Show all 9Show fewer
- Pathological conditions of lower limbs causing non-venous pain
- Use of vasoactive medications within 1 month before/after surgery
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First- or Second- Class Compression Hosiery After Endovenous Laser With Sclerotherapy and Ambulatory Phlebectomy: Randomized Controlled Trial (FISCHER)
Investigators hypothesize that first class compression therapy during the postoperative period will improve patient adherence due to easier application and reduced discomfort. Therefore, planning to compare the effectiveness of fist class versus second class compression therapy two weeks after EVLA of the great saphenous vein with concomitant combined sclerotherapy and ambulatory phlebectomy of tributaries.
Read the detailed description
In recent decades, significant advancements have emerged in varicose vein treatment. Endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) have become the leading techniques for eliminating trunk reflux, while microfoam sclerotherapy and ambulatory phlebectomy are most commonly used for treating tributaries. Post-intervention, patients typically receive recommendations to wear second-class compression stockings to reduce postoperative pain, ecchymosis, and hematomas. However, the optimal duration, regimen, and compression class remain poorly defined. Meanwhile, a growing surgical community advocates for eliminating compression therapy during the postoperative period altogether, citing low patient compliance rates (15-74%). The primary factors driving non-compliance include discomfort while wearing hosiery and difficulties with donning and doffing, suggesting compression hosiery characteristics may significantly impact adherence. Recent meta-analyses support compression therapy's benefits, demonstrating reduced postoperative pain levels and faster return to normal activities among patients using postoperative compression. Additionally, both national and international clinical guidelines recommend compression therapy for at least one week following thermal ablations. Investigators hypothesize that first class compression therapy during the postoperative period will improve patient adherence due to easier application and reduced discomfort. Therefore, planning to compare the effectiveness of first class versus second class compression therapy two weeks after EVLA of the great saphenous vein with concomitant combined sclerotherapy and ambulatory phlebectomy of tributaries.
- Conditions
- Varicose Veins, Chronic Venous Disorder, Chronic Venous Insufficiency (CVI), Venous Reflux, Great Saphenous Vein (GSV) With Venous Reflux Disease
- Being tested
- class I compression stockings of the RAL-GZ 387 standard: 1 month using, class II compression stockings of the RAL-GZ 387 standard: 1 month using
- Keywords
- Varicose veins, Varicose disease, Compression therapy, medical compression stockings, MCS, venous disease, veins, vein surgery, elastic hosiery, compression hosiery, endovenous laser, endovenous laser ablation, thermal ablation, sclerotherapy, microsclerotherapy, phlebectomy, ambulatory phlebectomy, elastic compression
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
class I compression stockings of the RAL-GZ 387 standard: 1 month usingDevice
Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) above-knee graduated compression stockings
class II compression stockings of the RAL-GZ 387 standard: 1 month 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 |
|---|---|---|
| Class 1 (18-21 mm Hg at the ankle level) above-knee graduated compression stockings | Experimental | All participants will undergo measurement of the affected limb at standard points to select the appropriate size of compression stockings. Then, the clinical class of chronic venous disease will be assessed for the study participants according to the CEAP classification, the severity of chronic venous disease will be evaluated using the VCSS scale, quality of life will be measured using the CIVIQ-20 questionnaire, and the intensity of venous-specific symptoms will be assessed using a numerical rating scale. After the surgical intervention, a class 1 compression stocking will be put on, which they will wear continuously for 24 hours; thereafter, it must be worn during the daytime for 28 days. Upon discharge, patients will receive a diary in which they will record postoperative pain and the fact of wearing the compression garment each day for 14 days. Follow-up visits will be scheduled for 14 days and 28 days after the surgical intervention. Receives: Device: class I compression stockings of the RAL-GZ 387 standard: 1 month using |
| Class 2 (23-32 mm Hg at the ankle level) above-knee graduated compression stockings | Active comparator | All participants will undergo measurement of the affected limb at standard points to select the appropriate size of compression stockings. Then, the clinical class of chronic venous disease will be assessed for the study participants according to the CEAP classification, the severity of chronic venous disease will be evaluated using the VCSS scale, quality of life will be measured using the CIVIQ-20 questionnaire, and the intensity of venous-specific symptoms will be assessed using a numerical rating scale. After the surgical intervention, a class 2 compression stocking will be put on, which they will wear continuously for 24 hours; thereafter, it must be worn during the daytime for 28 days. Upon discharge, patients will receive a diary in which they will record postoperative pain and the fact of wearing the compression garment each day for 14 days. Follow-up visits will be scheduled for 14 days and 28 days after the surgical intervention. Receives: Device: class II compression stockings of the RAL-GZ 387 standard: 1 month using |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of postoperative pain at 14 days
The intensity of postoperative pain is subjectively assessed by the patient on a 10-centimeter numeric scale daily. The range is from 0 (no pain) to 10 (pain of maximal intensity).
Measured: 14 days
Secondary outcomes (15)
Area (centimeter square) of ecchymosis
Assessed by an expert by measuring ecchymoses using a specialized smartphone application "LesionMeter".
Measured: 14 days
Number of patients with clinical manifestations of phlebitis at 14 days
Clinical significant appearance of signs of inflammation (hyperemia, swelling, pain) of the superficial veins
Measured: 14 days
The change of clinical class of chronic venous disease according to the CEAP classification in the operated lower limb at 28 days
The class of chronic venous disease in the operated lower limb is assessed by an expert during a clinical examination based on the CEAP classification.
Measured: 28 days
VCSS score at 14 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: 14 days
VCSS score 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 intensity of primary venous-specific symptoms on the operated lower limb according to a numerical rating scale at 14 days
Venous-specific symptoms are assessed by the patient independently using a numerical rating scale. The range is from 0 to 100, with a minimum score indicating the best quality of life.
Measured: 14 days
The intensity of primary venous-specific symptoms on the operated lower limb according to a numerical rating scale at 28 days
Venous-specific symptoms are assessed by the patient independently using a numerical rating scale. The range is from 0 to 100, with a minimum score indicating the best quality of life.
Measured: 28 days
CIVIQ-20 score at 14 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: 14 days
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
Compliance with the use of Medical Compression Stockings (MCS)
Compliance with the use of MCS is assessed based on the study of the patient's diaries in Groups 1 and 2 as a proportion of the number of days when the patient used MCS for at least 8 hours to the total duration of prescribed compression (14 days), represented as a percentage (n[MCS]/14*100%). It ranges from 0% (no compliance) to 100% (absolute compliance).
Measured: 14 days
Comfort with the use of MCS at 14 days
The patients subjectively assess their comfort when using MCS using a 100-cm numeric rating scale, which ranges from 0 (no comfort) to 10 (absolute comfort).
Measured: 14 days
Comfort with the use of MCS at 28 days
The patients subjectively assess their comfort when using MCS using a 100-cm numeric rating scale, which ranges from 0 (no comfort) to 10 (absolute comfort).
Measured: 28 days
Difficulty in putting on a compression stocking at 14 days
Patients subjectively assess the level of difficulty in putting on the compression stockings using a 100-point numerical scale, which ranges from 0 (no difficulty) to 100 (absolute difficulty).
Measured: 14 days
Difficulty in putting on a compression stocking at 28 days
Patients subjectively assess the level of difficulty in putting on the compression stockings using a 100-point numerical scale, which ranges from 0 (no difficulty) to 100 (absolute difficulty).
Measured: 28 days
The circumference length of the narrowest part of the calf above the ankle one month after the intervention at 28 days
The circumference length of the narrowest part of the calf was measured by an expert using a measuring tape.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start7 Apr 2025
- Primary completion1 Jul 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies 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, non-inferiority randomized controlled trial with a blinded outcome assessor
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow City Hospital named after A.K. Eramishantsev
- Sponsor type
- Other government
- Collaborators
- Pirogov Russian National Research Medical University, Vishnevsky Center of Surgery
- Responsible party
- Sponsor
- Investigators
- Hovsep P. Manjikian, MD, Study chair, Moscow City Hospital named after A.K. EramishantsevBoris Danelian, MD, Principal investigator, Moscow City Hospital named after A.K. EramishantsevHovsep Manjikyan, MD, Principal investigator, Moscow City Hospital named after A.K. Eramishantsev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913764
- Sponsor's protocol ID
- 1/2025
- Acronym
- FISCHER
- Status last verified
- Jul 2025
- First submitted
- 31 Mar 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Local regulations
Publications
Rabe E, Partsch H, Hafner J, Lattimer C, Mosti G, Neumann M, Urbanek T, Huebner M, Gaillard S, Carpentier P. Indications for medical compression stockings in venous and lymphatic disorders: An evidence-based consensus statement. Phlebology. 2018 Apr;33(3):163-184. doi: 10.1177/0268355516689631. Epub 2017 Feb 22.
PubMed 28549402Ma F, Xu H, Zhang J, Premaratne S, Gao H, Guo X, Yang T. Compression Therapy Following Endovenous Thermal Ablation of Varicose Veins: A Systematic Review and Meta-Analysis. Ann Vasc Surg. 2022 Mar;80:302-312. doi: 10.1016/j.avsg.2021.09.035. Epub 2021 Nov 11.
PubMed 34774690Hu H, Wang J, Wu Z, Liu Y, Ma Y, Zhao J. No Benefit of Wearing Compression Stockings after Endovenous Thermal Ablation of Varicose Veins: A Systematic Review and Meta-Analysis. Eur J Vasc Endovasc Surg. 2022 Jan;63(1):103-111. doi: 10.1016/j.ejvs.2021.09.034. Epub 2021 Nov 11.
PubMed 34776296Reich-Schupke S, Murmann F, Altmeyer P, Stucker M. Quality of life and patients' view of compression therapy. Int Angiol. 2009 Oct;28(5):385-93.
PubMed 19935593Kankam HKN, Lim CS, Fiorentino F, Davies AH, Gohel MS. A Summation Analysis of Compliance and Complications of Compression Hosiery for Patients with Chronic Venous Disease or Post-thrombotic Syndrome. Eur J Vasc Endovasc Surg. 2018 Mar;55(3):406-416. doi: 10.1016/j.ejvs.2017.11.025. Epub 2018 Jan 9.
PubMed 29329662Ayala A, Guerra JD, Ulloa JH, Kabnick L. Compliance with compression therapy in primary chronic venous disease: Results from a tropical country. Phlebology. 2019 May;34(4):272-277. doi: 10.1177/0268355518798153. Epub 2018 Sep 6.
PubMed 30189813Raju S, Hollis K, Neglen P. Use of compression stockings in chronic venous disease: patient compliance and efficacy. Ann Vasc Surg. 2007 Nov;21(6):790-5. doi: 10.1016/j.avsg.2007.07.014.
PubMed 17980798Nicolaides A, Kakkos S, Baekgaard N, Comerota A, de Maeseneer M, Eklof B, Giannoukas AD, Lugli M, Maleti O, Myers K, Nelzen O, Partsch H, Perrin M. Management of chronic venous disorders of the lower limbs. Guidelines According to Scientific Evidence. Part I. Int Angiol. 2018 Jun;37(3):181-254. doi: 10.23736/S0392-9590.18.03999-8. No abstract available.
PubMed 29871479Gianesini S, Obi A, Onida S, Baccellieri D, Bissacco D, Borsuk D, Campisi C, Campisi CC, Cavezzi A, Chi YW, Chunga J, Corda D, Crippa A, Davies A, De Maeseneer M, Diaz J, Ferreira J, Gasparis A, Intriago E, Jawien A, Jindal R, Kabnick L, Latorre A, Lee BB, Liew NC, Lurie F, Meissner M, Menegatti E, Molteni M, Morrison N, Mosti G, Narayanan S, Pannier F, Parsi K, Partsch H, Rabe E, Raffetto J, Raymond-Martimbeau P, Rockson S, Rosukhovski D, Santiago FR, Schul A, Schul M, Shaydakov E, Sibilla MG, Tessari L, Tomaselli F, Urbanek T, van Rijn MJ, Wakefield T, Wittens C, Zamboni P, Bottini O. Global guidelines trends and controversies in lower limb venous and lymphatic disease: Narrative literature revision and experts' opinions following the vWINter international meeting in Phlebology, Lymphology & Aesthetics, 23-25 January 2019. Phlebology. 2019 Sep;34(1 Suppl):4-66. doi: 10.1177/0268355519870690. No abstract available.
PubMed 31495256Lurie F, Lal BK, Antignani PL, Blebea J, Bush R, Caprini J, Davies A, Forrestal M, Jacobowitz G, Kalodiki E, Killewich L, Lohr J, Ma H, Mosti G, Partsch H, Rooke T, Wakefield T. Compression therapy after invasive treatment of superficial veins of the lower extremities: Clinical practice guidelines of the American Venous Forum, Society for Vascular Surgery, American College of Phlebology, Society for Vascular Medicine, and International Union of Phlebology. J Vasc Surg Venous Lymphat Disord. 2019 Jan;7(1):17-28. doi: 10.1016/j.jvsv.2018.10.002.
PubMed 30554745Kolluri R, Hays KU, Gohel MS. Foam Sclerotherapy Augmented Phlebectomy (SAP) Procedure for Varicose Veins: Report of a Novel Technique. EJVES Short Rep. 2018 Nov 16;41:16-18. doi: 10.1016/j.ejvssr.2018.10.007. eCollection 2018.
PubMed 30519649Carradice D, Mekako AI, Hatfield J, Chetter IC. Randomized clinical trial of concomitant or sequential phlebectomy after endovenous laser therapy for varicose veins. Br J Surg. 2009 Apr;96(4):369-75. doi: 10.1002/bjs.6556.
PubMed 19283745De Maeseneer MG, Kakkos SK, Aherne T, Baekgaard N, Black S, Blomgren L, Giannoukas A, Gohel M, de Graaf R, Hamel-Desnos C, Jawien A, Jaworucka-Kaczorowska A, Lattimer CR, Mosti G, Noppeney T, van Rijn MJ, Stansby G, Esvs Guidelines Committee, Kolh P, Bastos Goncalves F, Chakfe N, Coscas R, de Borst GJ, Dias NV, Hinchliffe RJ, Koncar IB, Lindholt JS, Trimarchi S, Tulamo R, Twine CP, Vermassen F, Wanhainen A, Document Reviewers, Bjorck M, Labropoulos N, Lurie F, Mansilha A, Nyamekye IK, Ramirez Ortega M, Ulloa JH, Urbanek T, van Rij AM, Vuylsteke ME. Editor's Choice - European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs. Eur J Vasc Endovasc Surg. 2022 Feb;63(2):184-267. doi: 10.1016/j.ejvs.2021.12.024. Epub 2022 Jan 11. No abstract available.
PubMed 35027279Gloviczki P, Lawrence PF, Wasan SM, Meissner MH, Almeida J, Brown KR, Bush RL, Di Iorio M, Fish J, Fukaya E, Gloviczki ML, Hingorani A, Jayaraj A, Kolluri R, Murad MH, Obi AT, Ozsvath KJ, Singh MJ, Vayuvegula S, Welch HJ. The 2023 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part II: Endorsed by the Society of Interventional Radiology and the Society for Vascular Medicine. J Vasc Surg Venous Lymphat Disord. 2024 Jan;12(1):101670. doi: 10.1016/j.jvsv.2023.08.011. Epub 2023 Aug 29.
PubMed 37652254Kamaev AA, Bulatov VL, Vakhratyan PE, Volkov AM, Volkov AS, Gavrilov EK, Golovina VI, Efremova OI, Ivanov OO, Ilyukhin EA, Katorkin SE, Konchugova TV, Kravtsov PF, Maksimov SV, Mzhavanadze ND, Pikhanova ZhM, Pryadko SI, Smirnov AA, Sushkov SA, Chabbarov RG, Shimanko AI, Yakushkin SN, Apkhanova TV, Derkachev SN, Zolotukhin IA, Kalinin RE, Kirienko AI, Kulchitskaya DB, Pelevin AV, Petrikov AS, Rachin AP, Seliverstov EI, Stoyko YuM, Suchkov IA. Clinical Guidelines. Varicose Veins. Flebologiya. 2022;16(1):41-108. (In Russ.). https://doi.org/10.17116/flebo20221601141
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First- or Second- Class Compression Hosiery After Endovenous Laser With Sclerotherapy and Ambulatory Phlebectomy: Randomized Controlled Trial (FISCHER)
- ClinicalTrials.gov ID
- NCT06913764
- Acronym / sponsor ID
- FISCHER / 1/2025
- Conditions
- Varicose Veins, Chronic Venous Disorder, Chronic Venous Insufficiency (CVI), Venous Reflux, Great Saphenous Vein (GSV) With Venous Reflux Disease
- Keywords
- Varicose veins, Varicose disease, Compression therapy, medical compression stockings, MCS, venous disease, veins, vein surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Moscow City Hospital named after A.K. EramishantsevOther government
- Collaborators
- Pirogov Russian National Research Medical University, Vishnevsky Center of Surgery
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 6 Apr 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.
Investigators hypothesize that first class compression therapy during the postoperative period will improve patient adherence due to easier application and reduced discomfort. Therefore, planning to compare the effectiveness of fist class versus second class compression therapy two weeks after EVLA of the great saphenous vein with concomitant combined sclerotherapy and ambulatory phlebectomy of tributaries.
Detailed description
In recent decades, significant advancements have emerged in varicose vein treatment. Endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) have become the leading techniques for eliminating trunk reflux, while microfoam sclerotherapy and ambulatory phlebectomy are most commonly used for treating tributaries. Post-intervention, patients typically receive recommendations to wear second-class compression stockings to reduce postoperative pain, ecchymosis, and hematomas. However, the optimal duration, regimen, and compression class remain poorly defined. Meanwhile, a growing surgical community advocates for eliminating compression therapy during the postoperative period altogether, citing low patient compliance rates (15-74%). The primary factors driving non-compliance include discomfort while wearing hosiery and difficulties with donning and doffing, suggesting compression hosiery characteristics may significantly impact adherence. Recent meta-analyses support compression therapy's benefits, demonstrating reduced postoperative pain levels and faster return to normal activities among patients using postoperative compression. Additionally, both national and international clinical guidelines recommend compression therapy for at least one week following thermal ablations. Investigators hypothesize that first class compression therapy during the postoperative period will improve patient adherence due to easier application and reduced discomfort. Therefore, planning to compare the effectiveness of first class versus second class compression therapy two weeks after EVLA of the great saphenous vein with concomitant combined sclerotherapy and ambulatory phlebectomy of tributaries.
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, non-inferiority randomized controlled trial with a blinded outcome assessor
| Arm | Type | Receives |
|---|---|---|
| Class 1 (18-21 mm Hg at the ankle level) above-knee graduated compression stockings | Experimental | Device: class I compression stockings of the RAL-GZ 387 standard: 1 month usingAll participants will undergo measurement of the affected limb at standard points to select the appropriate size of compression stockings. Then, the clinical class of chronic venous disease will be assessed for the study participants according to the CEAP classification, the severity of chronic venous disease will be evaluated using the VCSS scale, quality of life will be measured using the CIVIQ-20 questionnaire, and the intensity of venous-specific symptoms will be assessed using a numerical rating scale. After the surgical intervention, a class 1 compression stocking will be put on, which they will wear continuously for 24 hours; thereafter, it must be worn during the daytime for 28 days. Upon discharge, patients will receive a diary in which they will record postoperative pain and the fact of wearing the compression garment each day for 14 days. Follow-up visits will be scheduled for 14 days and 28 days after the surgical intervention. |
| Class 2 (23-32 mm Hg at the ankle level) above-knee graduated compression stockings | Active comparator | Device: class II compression stockings of the RAL-GZ 387 standard: 1 month usingAll participants will undergo measurement of the affected limb at standard points to select the appropriate size of compression stockings. Then, the clinical class of chronic venous disease will be assessed for the study participants according to the CEAP classification, the severity of chronic venous disease will be evaluated using the VCSS scale, quality of life will be measured using the CIVIQ-20 questionnaire, and the intensity of venous-specific symptoms will be assessed using a numerical rating scale. After the surgical intervention, a class 2 compression stocking will be put on, which they will wear continuously for 24 hours; thereafter, it must be worn during the daytime for 28 days. Upon discharge, patients will receive a diary in which they will record postoperative pain and the fact of wearing the compression garment each day for 14 days. Follow-up visits will be scheduled for 14 days and 28 days after the surgical intervention. |
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 ≥18 years
- Varicose veins of the lower extremities (CEAP classification C2-C5)
- Varicose disease in the great saphenous vein (GSV) and its tributaries
- Planned endovenous laser ablation of the GSV trunk with concomitant combined sclerotherapy and phlebectomy of tributaries
- Technical success of intervention (complete ablation of the GSV)
Key exclusion criteria (9 listed)
- Primary reflux outside the GSV trunk
- History of or acute deep vein thrombosis
- Deep vein insufficiency
- GSV recanalization post-intervention
- Clinical class C6 of chronic venous disease (CVD) according to CEAP classification
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 |
|---|---|---|
| class I compression stockings of the RAL-GZ 387 standard: 1 month usingClass 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) above-knee graduated compression stockings | Device | Class 1 (18-21 mm Hg at the ankle level) above-knee graduated compression stockings |
| class II compression stockings of the RAL-GZ 387 standard: 1 month usingClass 2 (RAL-GZ 387 standard: 23-32 mm Hg at the ankle level) above-knee graduated compression stockings | Device | Class 2 (23-32 mm Hg at the ankle level) above-knee graduated compression stockings |
Primary outcome
Level of postoperative pain at 14 days
Time frame: 14 days
The intensity of postoperative pain is subjectively assessed by the patient on a 10-centimeter numeric scale daily. The range is from 0 (no pain) to 10 (pain of maximal intensity).
15 secondary outcomes
Area (centimeter square) of ecchymosis
Time frame: 14 days
Number of patients with clinical manifestations of phlebitis at 14 days
Time frame: 14 days
The change of clinical class of chronic venous disease according to the CEAP classification in the operated lower limb at 28 days
Time frame: 28 days
VCSS score at 14 days
Time frame: 14 days
VCSS score at 28 days
Time frame: 28 days
The intensity of primary venous-specific symptoms on the operated lower limb according to a numerical rating scale at 14 days
Time frame: 14 days
The intensity of primary venous-specific symptoms on the operated lower limb according to a numerical rating scale at 28 days
Time frame: 28 days
CIVIQ-20 score at 14 days
Time frame: 14 days
CIVIQ-20 score at 28 days
Time frame: 28 days
Compliance with the use of Medical Compression Stockings (MCS)
Time frame: 14 days
Comfort with the use of MCS at 14 days
Time frame: 14 days
Comfort with the use of MCS at 28 days
Time frame: 28 days
Difficulty in putting on a compression stocking at 14 days
Time frame: 14 days
Difficulty in putting on a compression stocking at 28 days
Time frame: 28 days
The circumference length of the narrowest part of the calf above the ankle one month after the intervention at 28 days
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Background: PubMed 28549402Rabe E, Partsch H, Hafner J, Lattimer C, Mosti G, Neumann M, Urbanek T, Huebner M, Gaillard S, Carpentier P. Indications for medical compression stockings in venous and lymphatic disorders: An evidence-based consensus statement. Phlebology. 2018 Apr;33(3):163-184. doi: 10.1177/0268355516689631. Epub 2017 Feb 22.
- Background: PubMed 34774690Ma F, Xu H, Zhang J, Premaratne S, Gao H, Guo X, Yang T. Compression Therapy Following Endovenous Thermal Ablation of Varicose Veins: A Systematic Review and Meta-Analysis. Ann Vasc Surg. 2022 Mar;80:302-312. doi: 10.1016/j.avsg.2021.09.035. Epub 2021 Nov 11.
- Background: PubMed 34776296Hu H, Wang J, Wu Z, Liu Y, Ma Y, Zhao J. No Benefit of Wearing Compression Stockings after Endovenous Thermal Ablation of Varicose Veins: A Systematic Review and Meta-Analysis. Eur J Vasc Endovasc Surg. 2022 Jan;63(1):103-111. doi: 10.1016/j.ejvs.2021.09.034. Epub 2021 Nov 11.
- Background: PubMed 19935593Reich-Schupke S, Murmann F, Altmeyer P, Stucker M. Quality of life and patients' view of compression therapy. Int Angiol. 2009 Oct;28(5):385-93.
- Background: PubMed 29329662Kankam HKN, Lim CS, Fiorentino F, Davies AH, Gohel MS. A Summation Analysis of Compliance and Complications of Compression Hosiery for Patients with Chronic Venous Disease or Post-thrombotic Syndrome. Eur J Vasc Endovasc Surg. 2018 Mar;55(3):406-416. doi: 10.1016/j.ejvs.2017.11.025. Epub 2018 Jan 9.
- Background: PubMed 30189813Ayala A, Guerra JD, Ulloa JH, Kabnick L. Compliance with compression therapy in primary chronic venous disease: Results from a tropical country. Phlebology. 2019 May;34(4):272-277. doi: 10.1177/0268355518798153. Epub 2018 Sep 6.
- Background: PubMed 17980798Raju S, Hollis K, Neglen P. Use of compression stockings in chronic venous disease: patient compliance and efficacy. Ann Vasc Surg. 2007 Nov;21(6):790-5. doi: 10.1016/j.avsg.2007.07.014.
- Background: PubMed 29871479Nicolaides A, Kakkos S, Baekgaard N, Comerota A, de Maeseneer M, Eklof B, Giannoukas AD, Lugli M, Maleti O, Myers K, Nelzen O, Partsch H, Perrin M. Management of chronic venous disorders of the lower limbs. Guidelines According to Scientific Evidence. Part I. Int Angiol. 2018 Jun;37(3):181-254. doi: 10.23736/S0392-9590.18.03999-8. No abstract available.
- Background: PubMed 31495256Gianesini S, Obi A, Onida S, Baccellieri D, Bissacco D, Borsuk D, Campisi C, Campisi CC, Cavezzi A, Chi YW, Chunga J, Corda D, Crippa A, Davies A, De Maeseneer M, Diaz J, Ferreira J, Gasparis A, Intriago E, Jawien A, Jindal R, Kabnick L, Latorre A, Lee BB, Liew NC, Lurie F, Meissner M, Menegatti E, Molteni M, Morrison N, Mosti G, Narayanan S, Pannier F, Parsi K, Partsch H, Rabe E, Raffetto J, Raymond-Martimbeau P, Rockson S, Rosukhovski D, Santiago FR, Schul A, Schul M, Shaydakov E, Sibilla MG, Tessari L, Tomaselli F, Urbanek T, van Rijn MJ, Wakefield T, Wittens C, Zamboni P, Bottini O. Global guidelines trends and controversies in lower limb venous and lymphatic disease: Narrative literature revision and experts' opinions following the vWINter international meeting in Phlebology, Lymphology & Aesthetics, 23-25 January 2019. Phlebology. 2019 Sep;34(1 Suppl):4-66. doi: 10.1177/0268355519870690. No abstract available.
- Background: PubMed 30554745Lurie F, Lal BK, Antignani PL, Blebea J, Bush R, Caprini J, Davies A, Forrestal M, Jacobowitz G, Kalodiki E, Killewich L, Lohr J, Ma H, Mosti G, Partsch H, Rooke T, Wakefield T. Compression therapy after invasive treatment of superficial veins of the lower extremities: Clinical practice guidelines of the American Venous Forum, Society for Vascular Surgery, American College of Phlebology, Society for Vascular Medicine, and International Union of Phlebology. J Vasc Surg Venous Lymphat Disord. 2019 Jan;7(1):17-28. doi: 10.1016/j.jvsv.2018.10.002.
- Background: PubMed 30519649Kolluri R, Hays KU, Gohel MS. Foam Sclerotherapy Augmented Phlebectomy (SAP) Procedure for Varicose Veins: Report of a Novel Technique. EJVES Short Rep. 2018 Nov 16;41:16-18. doi: 10.1016/j.ejvssr.2018.10.007. eCollection 2018.
- Background: PubMed 19283745Carradice D, Mekako AI, Hatfield J, Chetter IC. Randomized clinical trial of concomitant or sequential phlebectomy after endovenous laser therapy for varicose veins. Br J Surg. 2009 Apr;96(4):369-75. doi: 10.1002/bjs.6556.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Local regulations
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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.
Hovsep P. Manjikian, MD study chair
Moscow City Hospital named after A.K. Eramishantsev
Boris Danelian, MD principal investigator
Moscow City Hospital named after A.K. Eramishantsev
Hovsep Manjikyan, MD principal investigator
Moscow City Hospital named after A.K. Eramishantsev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing class I compression stockings of the RAL-GZ 387 standard: 1 month using and class II compression stockings of the RAL-GZ 387 standard: 1 month using in people with Varicose Veins and Chronic Venous Disorder, run by Moscow City Hospital named after A.K. Eramishantsev 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 9 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: finished, as of the sponsor's last update on 8 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Level of postoperative pain at 14 days (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06913764, which also lists 17 linked publications.
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 8 Jul 2025.