Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05766579

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

Led by IRCCS Policlinico S. Donato · Updated on 2025-05-06

64

Participants Needed

1

Research Sites

404 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients older than 18 years
  • Varicose vein disease in lower limbs classified as C2 or C3 by CEAP
  • Incontinence of the great saphenous vein confirmed by Echo-Duplex
  • Candidates for radiofrequency thermal ablation of the great saphenous vein with phlebectomy of the affected leg
Not Eligible

You will not qualify if you...

  • Patients under 18 years old or those who do not consent to participate
  • Severe arterial disease of lower limbs (ankle-brachial index below 0.5)
  • Obesity with body mass index over 30
  • Varicose vein disease classified as C4 to C6 by CEAP (with skin changes or ulcers)
  • Pregnancy

AI-Screening

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Trial Site Locations

Total: 1 location

1

I.R.C.C.S. Policlinico San Donato

San Donato Milanese, Milan, Italy, 20097

Actively Recruiting

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Research Team

D

Daniela Mazzaccaro, MD, PhD

CONTACT

G

Giovanni Nano, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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