CVR Registry Evaluating Flexitouch Plus and Conservative Care vs Conservative Care Only for Treatment of Lymphedema

Exclusion Criteria

• •1. BMI \> 50.
• •2. 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).
• •3. Unresolved healing at the surgical site following a venous intervention (e.g., ablation, stenting, or venoplasty).
• •4. Heart failure (acute pulmonary edema, decompensated acute heart failure).
• •5. Acute venous disease (\< 6 weeks) such as acute thrombophlebitis, acute deep venous thrombosis, or acute pulmonary embolism.
• •6. Significant peripheral artery disease (ankle-brachial index (ABI) \< 0.6, critical limb ischemia including ischemic rest pain, arterial wounds or gangrene).
• •7. Active skin or limb infection/ inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease).
• •8. Active cancer (cancer that is currently under treatment, but not yet in remission).
• •9. Poorly controlled kidney disease (glomerular filtration rate \< 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism, cyclic edema, or Munchausen Syndrome.
• •10. Any circumstance where increased lymphatic or venous return is undesirable.
• •11. Currently pregnant or trying to become pregnant (for Flexitouch Plus and conservative care group).
• •12. Current participation in any drug or other device clinical studies.