Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT03904602
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03904602
Study Brief:
Protocol Section:
NCT03904602