A Preference Study of Two Pneumatic Compression Devices for Patients With Lower Limb Lymphedema
Completed · Not applicable
Conditions studied: Lymphedema of Leg, Lymphedema, Lymphedema, Secondary, Lymphedema Primary, Lymphedema, Lower Limb
In brief
This study will aim to undertake a preference evaluation comparing the Aria Health Aria Free™ to a competitor's device by assessing overall satisfaction and preference of the devices individually and in comparison to one another. Twenty (20) subjects will be enrolled on this study at one study site in Houston, Texas.
Key facts
- Study ID
- NCT05485454
- Run by
- ResMed
- People needed
- 20
- Starts
- 2022-06-11
- Expected to finish
- 2022-07-30
- Last updated by the study team
- 2022-09-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female patients who are ≥ 18 years, mentally able to understand and follow the instructions of the study personnel
- A diagnosis of unilateral or bilateral lower limb lymphedema
- A physician's prescription for use of a pneumatic compression device
- Able to provide written informed consent
- Patient can read and comprehend English
- Study leg must be within fit range of the Aria Free Garment (Ankle Max = 35cm/13.78in; Thigh Max = 80cm/34.49in)
You may not qualify if…
- Subject undergoing cancer treatment
- Subject has active lower limb wounds
- Subject is pregnant or trying to become pregnant
- History of pulmonary edema or decompensated congestive heart failure
- Subject has any condition in which increased venous and lymphatic return is undesirable
- Subject has inbuilt electrical stimulator, e.g., cardiac pacemaker
- Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
- Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene)
- Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease)
Where it is running
- Lymphatic Solutions, LLC — Houston, Texas, United States
Full record on ClinicalTrials.gov
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