Comparison Trial Between Elastic-compressive Stockings at 21 Versus 32 mmHg
NCT ID: NCT05766579
Last Updated: 2025-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
64 participants
INTERVENTIONAL
2019-04-02
2026-12-31
Brief Summary
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Despite this, the duration, type and degree of compression to be used, particularly after radiofrequency ablation procedures, remain a matter of debate. Furthermore, although the benefits of postoperative elastic compression therapy are well known, there is various evidence demonstrating how patients often experience poor comfort in wearing stockings, especially those with a higher degree of compression, which causes poor compliance with therapy. In light of all this, each center recommends the use of elastic compression stockings in the postoperative period with a degree of compression that varies, however, according to internal protocols.
There is currently no work in the literature that compares the advantages and disadvantages of using elastic compression stockings with a K2 versus K1 compression degree after radiofrequency ablative surgery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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K1, 18-21 mmHg
Use of elastic stockings at 18-21 mmHg after endovenous thermal ablation
Elastic-compressive stockings
Use of Elastic-compressive stockings at 21 mmHg and 32 mmHg.
K2, 23-32 mmHg
Use of elastic stockings at 23-32 mmHg after endovenous thermal ablation
Elastic-compressive stockings
Use of Elastic-compressive stockings at 21 mmHg and 32 mmHg.
Interventions
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Elastic-compressive stockings
Use of Elastic-compressive stockings at 21 mmHg and 32 mmHg.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Presence of severe obliterating arterial disease of the lower limbs (ABI \<0.5)
* Obesity (BMI \>30)
* Varicose pathology of the lower limbs in C4-C6 class according to Clinic, Etiology, Anatomy, Pathophysiology (CEAP) classification (presence of:
lipodermatosclerosis/eczema and/or ulcers in progress and/or previous ulcers in the affected lower limb).
* Pregnancy.
18 Years
ALL
No
Sponsors
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IRCCS Policlinico S. Donato
OTHER
Responsible Party
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Daniela Mazzaccaro
Medical Doctor and Researcher
Locations
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I.R.C.C.S. Policlinico San Donato
San Donato Milanese, Milan, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Wittens C, Davies AH, Baekgaard N, Broholm R, Cavezzi A, Chastanet S, de Wolf M, Eggen C, Giannoukas A, Gohel M, Kakkos S, Lawson J, Noppeney T, Onida S, Pittaluga P, Thomis S, Toonder I, Vuylsteke M, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Koncar I, Lindholt J, de Ceniga MV, Vermassen F, Verzini F, Document Reviewers, De Maeseneer MG, Blomgren L, Hartung O, Kalodiki E, Korten E, Lugli M, Naylor R, Nicolini P, Rosales A. Editor's Choice - Management of Chronic Venous Disease: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2015 Jun;49(6):678-737. doi: 10.1016/j.ejvs.2015.02.007. Epub 2015 Apr 25. No abstract available.
Onida S, Lane TR, Davies AH. Phlebectomies: to delay or not to delay? Phlebology. 2012 Apr;27(3):103-4. doi: 10.1258/phleb.2012.011130. No abstract available.
Huang TW, Chen SL, Bai CH, Wu CH, Tam KW. The optimal duration of compression therapy following varicose vein surgery: a meta-analysis of randomized controlled trials. Eur J Vasc Endovasc Surg. 2013 Apr;45(4):397-402. doi: 10.1016/j.ejvs.2013.01.030. Epub 2013 Feb 19.
Reich-Schupke S, Feldhaus F, Altmeyer P, Mumme A, Stucker M. Efficacy and comfort of medical compression stockings with low and moderate pressure six weeks after vein surgery. Phlebology. 2014 Jul;29(6):358-66. doi: 10.1177/0268355513484142. Epub 2013 May 3.
Ye K, Wang R, Qin J, Yang X, Yin M, Liu X, Jiang M, Lu X. Post-operative Benefit of Compression Therapy after Endovenous Laser Ablation for Uncomplicated Varicose Veins: A Randomised Clinical Trial. Eur J Vasc Endovasc Surg. 2016 Dec;52(6):847-853. doi: 10.1016/j.ejvs.2016.09.005. Epub 2016 Oct 17.
Bakker NA, Schieven LW, Bruins RM, van den Berg M, Hissink RJ. Compression stockings after endovenous laser ablation of the great saphenous vein: a prospective randomized controlled trial. Eur J Vasc Endovasc Surg. 2013 Nov;46(5):588-92. doi: 10.1016/j.ejvs.2013.08.001. Epub 2013 Sep 5.
Cavezzi A, Mosti G, Colucci R, Quinzi V, Bastiani L, Urso SU. Compression with 23 mmHg or 35 mmHg stockings after saphenous catheter foam sclerotherapy and phlebectomy of varicose veins: A randomized controlled study. Phlebology. 2019 Mar;34(2):98-106. doi: 10.1177/0268355518776127. Epub 2018 May 12.
El-Sheikha J, Carradice D, Nandhra S, Leung C, Smith GE, Wallace T, Campbell B, Chetter IC. A systematic review of the compression regimes used in randomised clinical trials following endovenous ablation. Phlebology. 2017 May;32(4):256-271. doi: 10.1177/0268355516648497. Epub 2016 May 12.
Weiss RA, Duffy D. Clinical benefits of lightweight compression: reduction of venous-related symptoms by ready-to-wear lightweight gradient compression hosiery. Dermatol Surg. 1999 Sep;25(9):701-4. doi: 10.1046/j.1524-4725.1999.99064.x.
Benigni JP, Sadoun S, Allaert FA, Vin F. Efficacy of Class 1 elastic compression stockings in the early stages of chronic venous disease. A comparative study. Int Angiol. 2003 Dec;22(4):383-92.
Liu R, Lao TT, Kwok YL, Li Y, Ying MT. Effects of graduated compression stockings with different pressure profiles on lower-limb venous structures and haemodynamics. Adv Ther. 2008 May;25(5):465-78. doi: 10.1007/s12325-008-0058-2.
El-Sheikha J, Carradice D, Nandhra S, Leung C, Smith GE, Campbell B, Chetter IC. Systematic review of compression following treatment for varicose veins. Br J Surg. 2015 Jun;102(7):719-25. doi: 10.1002/bjs.9788. Epub 2015 Apr 2.
Garratt AM, Macdonald LM, Ruta DA, Russell IT, Buckingham JK, Krukowski ZH. Towards measurement of outcome for patients with varicose veins. Qual Health Care. 1993 Mar;2(1):5-10. doi: 10.1136/qshc.2.1.5.
Krasznai AG, Sigterman TA, Troquay S, Houtermans-Auckel JP, Snoeijs M, Rensma HG, Sikkink C, Bouwman LH. A randomised controlled trial comparing compression therapy after radiofrequency ablation for primary great saphenous vein incompetence. Phlebology. 2016 Mar;31(2):118-24. doi: 10.1177/0268355514568658. Epub 2015 Jan 23.
Other Identifiers
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41/int/2019
Identifier Type: -
Identifier Source: org_study_id
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