CVR Registry Evaluating Flexitouch Plus and Conservative Care vs Conservative Care Only for Treat… (NCT04116099) | Clinical Trial Compass
TerminatedNot Applicable
CVR Registry Evaluating Flexitouch Plus and Conservative Care vs Conservative Care Only for Treatment of Lymphedema
Stopped: Covid impact - slow enrollment
United States63 participantsStarted 2019-10-10
Plain-language summary
Subjects with lower extremity lymphedema will be prescribed, per standard of care, to either Flexitouch Plus with conservative care or conservative care only and be followed for 12 months.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female 18 years of age or older.
✓. Diagnosis of lower extremity lymphedema (including primary, secondary, chronic venous insufficiency (CVI)-related, unilateral, or bilateral).
✓. Clinical Etiology Anatomy Pathophysiology (CEAP) Classification of C3 or higher.
✓. Willing to comply with prescribed care, protocol requirements, and study-related visits.
✓. Willing and able to provide consent to participate.
Exclusion criteria
✕. BMI \> 50.
✕. Significant venous reflux disease, as determined by the investigator (e.g., indicated for venous intervention, post intervention with inadequate venous function, or ultrasound evidence of deep venous obstruction).
✕. Unresolved healing at the surgical site following a venous intervention (e.g., ablation, stenting, or venoplasty).