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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT04837560
Eligibility Criteria:
Inclusion Criteria:
1. Subjects must be between 18 to 80 years old
2. Venous edema patients diagnosed by an indent in the skin following finger pressure.
3. Venous edema in both calves
4. Temporarily or permanently wheelchair users which are expected to remain so according to the investigator's discretion
5. Subjects able to provide a written informed consent
6. No existence of DVT according to leg deep vein Duplex test
Exclusion Criteria as reported by patients: :
1. Positive pregnancy test
2. Breastfeeding woman
3. moderate or severe Congestive heart failure
4. Cellulitis of tissues of the lower limb.
5. Infectious Dermatitis of the lower limb
6. Acute or within 6 weeks of a deep vein thrombosis (DVT).
7. Postphlebetic patients
8. Known hypersensitivity to any component of the device
9. Subjects unable to provide informed consent
10. Active cancer at the root of the limb or in the adjacent quadrant
11. Any limitation of renal function- according to the investigator's discretion
12. Any limitation of liver function - according to the investigator's discretion
13. Subject who cannot commit to a month of intensive standard therapy
14. Wound or other skin condition that, according to the investigator's discretion, might be aggravated by the garment
15. Currently participating in another clinical trial or have completed their participation in a clinical trial within 30 days of screening
16. Other physical and/or mental conditions that, according to the investigator's discretion, prevent the subject from participating in the trial and completing its assessments
17. Cardiac or cerebral pacemaker or stimulator
18. Patients after orthopedic / vascular injury in the lower extremities
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04837560
Study Brief:
Protocol Section:
NCT04837560