Comparing different levels of compression stockings after varicose vein treatment
ElaStic-compressive Stockings at 21 mmHg and 32 mmHg Following Thermal Ablation of the Great Saphenous Vein.
This study is testing whether wearing different levels of compression stockings after varicose vein treatment helps patients feel more comfortable and reduces complications like pain and swelling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milan) |
| Trial ID | NCT05766579 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of elastic-compressive stockings with different pressure levels (21 mmHg vs. 32 mmHg) in patients undergoing endovenous thermal ablation for varicose veins. The study aims to determine which level of compression provides better postoperative comfort and reduces complications such as pain, edema, and thrombosis. Participants will be adult patients diagnosed with varicose veins and scheduled for thermal ablation procedures. The trial will assess patient compliance and outcomes related to the use of these stockings.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with varicose vein pathology classified as C2-3 and scheduled for thermal ablation.
Not a fit: Patients with severe arterial disease, obesity, advanced varicose pathology, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative comfort and reduced complications for patients undergoing varicose vein treatments.
How similar studies have performed: Other studies have explored the use of compression therapy post-surgery, but this specific comparison of compression levels is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Donato Milanese, Milan
- I.R.C.C.S. Policlinico San Donato — San Donato Milanese, Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Daniela Mazzaccaro, MD, PhD
- Email: daniela.mazzaccaro@grupposandonato.it
- Phone: + 39 025277
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.