Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumat… (NCT06418282) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema
United States100 participantsStarted 2024-05-13
Plain-language summary
An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion Criteria:
* Males and females ≥ 18 years of age
* Capable and willing to sign the informed consent and deemed capable of following the study protocol
* Subjects must have a diagnosis of unilateral or bilateral lower extremity edema or lower extremity lymphedema/phlebolymphedema as a consequence of chronic venous insufficiency
* Subjects who have medical clearance using diagnostic confirmation through venous duplex to rule out DVT and superficial/deep reflux
Exclusion Criteria:
* Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
* Individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy
* Subjects must not have any diagnosed cognitive or physical impairment that would interfere with the use of the device
* Non-ambulatory individuals
* Female: BMI \> 34 (5'4", 200 lbs.)
* Male: BMI \> 34 (5'9", 230 lbs.)
* (Max circumference at patella 58 cm; Max circumference at gluteal fold 75 cm)
* 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 active/open wound/ulcer
* Diagnosis of acute thrombophlebitis (in last 2 months)
* Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
* Diagnosis of pu…
What they're measuring
1
Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)