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Active, not recruiting Not applicable

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

NCT05766579 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2019-04-02
Last updated
2026-07-02

Condition(s) studied

Vascular Surgical Procedures

Investigational drug(s) / intervention(s)

Elastic-compressive stockings

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Postoperative Pain — 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 — 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)

Trial sites (1)

FacilityCityRegionStatus
I.R.C.C.S. Policlinico San Donato San Donato Milanese Milan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05766579 on ClinicalTrials.gov ↗ ← All trials in Italy