Vascular Surgical ProceduresCALESSENCT05766579

Comparison Trial Between Elastic-compressive Stockings at 21 Versus 32 mmHg

A study testing Elastic-compressive stockings in people with Vascular Surgical Procedures, run by IRCCS Policlinico S. Donato at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Vascular Surgical Procedures
What is being tested?: Elastic-compressive stockings
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteItaly
Study dates: 2 Apr 2019to 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

adult patients (>18 years) suffering from varicose vein pathology of the lower limbs C2-3 class (varicose veins, edema) according to Clinic, Etiology, Anatomy, Pathophysiology (CEAP) classification, supported by incontinence of the great saphenous vein documented by Echo-Duplex study and candidates for thermal ablation by radiofrequency of the great vein saphenous vein with associated phlebectomy of the ipsilateral thigh and/or leg varices.

Who cannot join

Patients who are minors (< 18 years old) or adults who have not given their consent to participate in the study.
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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

I.R.C.C.S. Policlinico San Donato
San Donato Milanese, Milan, 20097

Other trials in Italy

About this study

Official title: ElaStic-compressive Stockings at 21 mmHg and 32 mmHg Following Thermal Ablation of the Great Saphenous Vein.

Endovascular thermal ablation is currently considered as the best procedure for treating varicose veins thanks to its mini-invasiveness and the lowest rate of incidence of complications. At the end of the endovascular ablation procedure, the European Society of Vascular Surgery (ESVS) guidelines recommend the use of the compression stockings to reduce postoperative pain and the incidence of edema and thrombotic complications.

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.

Conditions: Vascular Surgical Procedures
Being tested: Elastic-compressive stockings
Keywords: Stockings, Compression, Thermoablation, Radiofrequency, Saphenous Vein

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Elastic-compressive stockingsDevice
Use of Elastic-compressive stockings at 21 mmHg and 32 mmHg.

Study groups in NCT05766579
Study group	Role	What they receive
K1, 18-21 mmHg	Experimental	Use of elastic stockings at 18-21 mmHg after endovenous thermal ablation Receives: Device: Elastic-compressive stockings
K2, 23-32 mmHg	Experimental	Use of elastic stockings at 23-32 mmHg after endovenous thermal ablation Receives: Device: Elastic-compressive stockings

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative Pain
Evaluation of postoperative pain using the Visual Analogic pain Scale (1-10, being higher the pain the higher the value of the scale)
Measured: 3 days after surgery
Postoperative Pain
Evaluation of postoperative pain using the Visual Analogic pain Scale (1-10, being higher the pain the higher the value of the scale)
Measured: 7 days after surgery

Secondary outcomes (15)

Lower limb edema
Evaluation of the circumference of the lower limb undergoing surgery in 3 points: 10 cm above the patella, at the level of the tibial tuberosity and 5 cm below the latter
Measured: 3 days from intervention
Lower limb edema
Evaluation of the circumference of the lower limb undergoing surgery in 3 points: 10 cm above the patella, at the level of the tibial tuberosity and 5 cm below the latter
Measured: 7 days from intervention
Lower limb edema
Evaluation of the circumference of the lower limb undergoing surgery in 3 points: 10 cm above the patella, at the level of the tibial tuberosity and 5 cm below the latter
Measured: 30 days from intervention
Analgesic Drugs Use
Evaluation of the possible use of analgesic drugs for postoperative pain.
Measured: 3 days from intervention
Analgesic Drugs Use
Evaluation of the possible use of analgesic drugs for postoperative pain.
Measured: 7 days from intervention
Analgesic Drugs Use
Evaluation of the possible use of analgesic drugs for postoperative pain.
Measured: 30 days from intervention
Discomfort
Evaluation of the discomfort caused to the patient by the use of stockings using the Aberdeen Varicose Veins Questionnaire .
Measured: 3 days from intervention
Discomfort
Evaluation of the discomfort caused to the patient by the use of stockings using the Aberdeen Varicose Veins Questionnaire .
Measured: 7 days from intervention
Discomfort
Evaluation of the discomfort caused to the patient by the use of stockings using the Aberdeen Varicose Veins Questionnaire .
Measured: 30 days from intervention
Postoperative Complications
Evaluation of the incidence of postoperative complications
Measured: 3 days from intervention
Postoperative Complications
Evaluation of the incidence of postoperative complications
Measured: 7 days from intervention
Postoperative Complications
Evaluation of the incidence of postoperative complications
Measured: 30 days from intervention
Evaluation of Quality of Life
Evaluation of the quality of life using a questionnaire
Measured: 3 days from intervention
Evaluation of Quality of Life
Evaluation of the quality of life using a questionnaire
Measured: 7 from intervention
Evaluation of Quality of Life
Evaluation of the quality of life using a questionnaire.
Measured: 30 days from intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 201931 Dec 2026

First posted13 Mar 2023
Study start2 Apr 2019
Primary completion30 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Vascular Surgical ProceduresStudies of the same condition, open and under way.
More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
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
Masking: None (open label)
Enrolment: 64 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05766579
Sponsor's protocol ID: 41/int/2019
Acronym: CALESSE
Status last verified: Jul 2026
First submitted: 17 Feb 2023
Last updated: 2 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The authors of the study are the owners of all data collected and will commit to the publication of the data themselves unconditionally and in full.

Publications

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.
PubMed 25920631
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.
PubMed 22457169
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.
PubMed 23433496
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.
PubMed 23563646
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.
PubMed 27760697
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.
PubMed 24012465
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.
PubMed 29754530
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.
PubMed 27178404
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.
PubMed 10491060
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.
PubMed 15153823
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.
PubMed 18523736
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.
PubMed 25833417
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.
PubMed 10132081
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.
PubMed 25616874

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ElaStic-compressive Stockings at 21 mmHg and 32 mmHg Following Thermal Ablation of the Great Saphenous Vein.
ClinicalTrials.gov ID: NCT05766579
Acronym / sponsor ID: CALESSE / 41/int/2019
Conditions: Vascular Surgical Procedures
Keywords: Stockings, Compression, Thermoablation, Radiofrequency, Saphenous Vein
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 64 participants (estimated)
Lead sponsor: IRCCS Policlinico S. DonatoUniversity, hospital or other
Study start: 2 Apr 2019 (actual)
Primary completion: 30 Dec 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 13 Mar 2023 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
K1, 18-21 mmHg	Experimental	Device: Elastic-compressive stockingsUse of elastic stockings at 18-21 mmHg after endovenous thermal ablation
K2, 23-32 mmHg	Experimental	Device: Elastic-compressive stockingsUse of elastic stockings at 23-32 mmHg after endovenous thermal ablation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

adult patients (>18 years) suffering from varicose vein pathology of the lower limbs C2-3 class (varicose veins, edema) according to Clinic, Etiology, Anatomy, Pathophysiology (CEAP) classification, supported by incontinence of the great saphenous vein documented by Echo-Duplex study and candidates for thermal ablation by radiofrequency of the great vein saphenous vein with associated phlebectomy of the ipsilateral thigh and/or leg varices.

Key exclusion criteria (6 listed)

Patients who are minors (< 18 years old) or adults who have not given their consent to participate in the study.
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).

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
Elastic-compressive stockingsUse of Elastic-compressive stockings at 21 mmHg and 32 mmHg.	Device	K1, 18-21 mmHg, K2, 23-32 mmHg

Primary outcome

Postoperative Pain
Time frame: 3 days after surgery
Evaluation of postoperative pain using the Visual Analogic pain Scale (1-10, being higher the pain the higher the value of the scale)
Postoperative Pain
Time frame: 7 days after surgery
Evaluation of postoperative pain using the Visual Analogic pain Scale (1-10, being higher the pain the higher the value of the scale)

15 secondary outcomes

Lower limb edema
Time frame: 3 days from intervention
Lower limb edema
Time frame: 7 days from intervention
Lower limb edema
Time frame: 30 days from intervention
Analgesic Drugs Use
Time frame: 3 days from intervention
Analgesic Drugs Use
Time frame: 7 days from intervention
Analgesic Drugs Use
Time frame: 30 days from intervention
Discomfort
Time frame: 3 days from intervention
Discomfort
Time frame: 7 days from intervention
Discomfort
Time frame: 30 days from intervention
Postoperative Complications
Time frame: 3 days from intervention
Postoperative Complications
Time frame: 7 days from intervention
Postoperative Complications
Time frame: 30 days from intervention
Evaluation of Quality of Life
Time frame: 3 days from intervention
Evaluation of Quality of Life
Time frame: 7 from intervention
Evaluation of Quality of Life
Time frame: 30 days from intervention

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 2 Jul 2026.
Background: PubMed 25920631Wittens 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.
Background: PubMed 22457169Onida 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.
Background: PubMed 23433496Huang 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.
Background: PubMed 23563646Reich-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.
Background: PubMed 27760697Ye 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.
Background: PubMed 24012465Bakker 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.
Background: PubMed 29754530Cavezzi 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.
Background: PubMed 27178404El-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.
Background: PubMed 10491060Weiss 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.
Background: PubMed 15153823Benigni 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.
Background: PubMed 18523736Liu 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.
Background: PubMed 25833417El-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.
Individual participant dataSharing planned: Yes. The authors of the study are the owners of all data collected and will commit to the publication of the data themselves unconditionally and in full.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Elastic-compressive stockings in people with Vascular Surgical Procedures, run by IRCCS Policlinico S. Donato at 1 site in Italy.

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 1 inclusion and 6 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 2 Jul 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 Italy. 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?

Postoperative Pain (time frame: 3 days after surgery). The study lists 2 primary outcomes in all. 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 NCT05766579, which also lists 14 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 2 Jul 2026.