Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects must be between 18 to 80 years old
Venous edema patients diagnosed by an indent in the skin following finger pressure.
Venous edema in both calves
Temporarily or permanently wheelchair users which are expected to remain so according to the investigator's discretion
Subjects able to provide a written informed consent
No existence of DVT according to leg deep vein Duplex test
Exclusion Criteria as reported by patients: :
Positive pregnancy test
Breastfeeding woman
moderate or severe Congestive heart failure
Cellulitis of tissues of the lower limb.
Infectious Dermatitis of the lower limb
Acute or within 6 weeks of a deep vein thrombosis (DVT).
Postphlebetic patients
Known hypersensitivity to any component of the device
Subjects unable to provide informed consent
Active cancer at the root of the limb or in the adjacent quadrant
Any limitation of renal function- according to the investigator's discretion
Any limitation of liver function - according to the investigator's discretion
Subject who cannot commit to a month of intensive standard therapy
Wound or other skin condition that, according to the investigator's discretion, might be aggravated by the garment
Currently participating in another clinical trial or have completed their participation in a clinical trial within 30 days of screening
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
Cardiac or cerebral pacemaker or stimulator
Patients after orthopedic / vascular injury in the lower extremities
Study Design
Connect with a study center
Sheba Medical Center at Tel HaShomer
Ramat Gan, 52621
IsraelActive - Recruiting
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