EdemaWear to Reduce Edema in Hospitalized Patients With CVI: (NCT03904602) | Clinical Trial Compass
TerminatedNot Applicable
EdemaWear to Reduce Edema in Hospitalized Patients With CVI:
Stopped: Patients experienced translocation of edema from lower extremities to trunk heightening concern about triggering congestive heart failure in frail elders.
United States3 participantsStarted 2019-08-19
Plain-language summary
The purpose of this pilot study is to evaluate the effectiveness of EdemaWear® fuzzy wale longitudinal compression stockings on reducing lower extremity edema in hospitalized adult patients with a history of CVI who are at high risk of consequent venous leg ulcers (VLU) and patient experience with continuously wearing Edema Wear for up to five days
Who can participate
Age range
18 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:
* history of CVI (Clinical classification 1-5), with \> 2+ edema of the lower legs,
* \> 2+ peripheral pulses (popliteal, dorsalis pedis \[DP\], and posterior tibial \[PT\]) or audible biphasic / triphasic Doppler signal, if pulses not palpable.
Exclusion Criteria:
* open venous stasis ulcer(s) or other wounds on lower legs
* lymphedema or risk factors for lymphedema
* acute heart failure with active management
* known deep vein thrombosis (DVT) with subtherapeutic anticoagulation
* peripheral arterial disease (PAD) with reduced / absent pulses
* known or suspected inferior vena caval (IVC) compression
* circumference of lower leg \< 45 cm or \> 115 cm (size limits of small and extra-large EdemaWear®)
* severely altered mental status or lacking capacity to consent.
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.