Study to Evaluate the Safety and Effectiveness of Dayspring for Lower Extremity Lymphedema (NCT04897035) | Clinical Trial Compass
CompletedNot Applicable
Study to Evaluate the Safety and Effectiveness of Dayspring for Lower Extremity Lymphedema
United States24 participantsStarted 2021-06-01
Plain-language summary
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males and females ≥ 18 years of age
* Willing to sign the informed consent and deemed capable of following the study protocol
* Subjects must have a diagnosis of primary or secondary unilateral lower extremity edema
* At the time of initial evaluation, individuals must be at least 3 months post surgery, chemotherapy and/or radiation treatment for cancer if applicable
Exclusion Criteria:
* Individuals with a history or presence of an acute systemic disorder or condition that could place the patient at increased risk from sequential compression therapy
* Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
* Patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
* Patients must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
* Diagnosis of lipedema
* Diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer)
* Diagnosis of Acute infection (in the last four weeks)
* Diagnosis of acute thrombophlebitis (in last 6 months)
* Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
* Diagnosis of pulmonary edema
* Diagnosis of congestive heart failure (uncontrolled)
* Diagnosis of chronic kidney disease with acute renal failure
* Diagnosis of epilepsy
* …
What they're measuring
1
LYMQOL (LYMphedema Quality of Life) ***All Relevant Time Points Used in the Calculation in the Time Frame (e.g., Baseline and 3 Months).***