A Multi-center Randomized Control Cross-over Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema (TEAYS) | NYU Langone Health

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A Multi-center Randomized Control Cross-over Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema (TEAYS)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Lymphedema
Age: Between 18 Year(s) - 99 Year(s)
Gender: Male or Female

Other Inclusion Criteria:
1. Males and females = 18 years of age.
2. Capable and willing to sign the informed consent and deemed capable of following the study protocol.
3. Participants must have a diagnosis of primary or secondary unilateral or bilateral lower extremity edema or lower extremity phlebolymphedema from chronic venous insufficiency.
4. Participants who have medical clearance for the safe application of limb compression, using diagnostic confirmation of a complete arterial Doppler study and/or Ankle-brachial Index (ABI) screening.

You may not be eligible for this study if the following are true:

1. Individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy.
2. Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent.
3. Individuals with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
4. Individuals must not have any diagnosed cognitive or physical impairment that would interfere with use of the device.
5. Diagnosis of:
  - lipedema;
  - active or recurrent cancer (< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer);
  - acute infection (in the last four weeks);
  - acute thrombophlebitis (in last 6 months);
  - pulmonary embolism or deep vein thrombosis within the previous 6 months;
  - pulmonary edema;
  - congestive heart failure (uncontrolled/uncompensated);
  - chronic kidney disease with acute renal failure;
  - epilepsy.
6. Individuals with poorly controlled asthma.
7. Any condition where increased venous and lymphatic return is undesirable.
8. Women who are pregnant, planning a pregnancy or nursing at study entry.
9. Participation in any clinical trial of an investigational substance or device during the past 30 days.