UnknownNot Applicable

Study to Evaluate Impact SANKOM Patent Socks in Patients With CVI

Ukraine30 participantsStarted 2018-02-05

Plain-language summary

Clinical study to evaluate impact on quality of life in patients with Chronic Venous Insufficiency during 4 weeks period of using SANKOM® Patent Socks

Who can participate

Age range

35 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject is informed and given ample time and opportunity to think about his/her participation and has given his/her written informed consent before any procedure;
. Subject is male or female, 35-65 years of age;
. Subject with chronic venous insufficiency CEAP (C1, C2);
. Subject can speak and understand Ukrainian or Russian language.

Exclusion criteria

. Subject participated in any clinical study (drug or device) within 6 months prior to the screening;
. Subject unable to wear compression stockings;
. Subject using other compression therapy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Improvement of health status in varicose veins patients

Timeframe: 4 weeks

Trial details

NCT IDNCT03445091

SponsorSankom SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-04-01

View on ClinicalTrials.gov More Chronic Venous Insufficiency trials