A Preference Study of Two Pneumatic Compression Devices for Patients With Lower Limb Lymphedema (NCT05485454) | Clinical Trial Compass
CompletedNot Applicable
A Preference Study of Two Pneumatic Compression Devices for Patients With Lower Limb Lymphedema
United States20 participantsStarted 2022-06-11
Plain-language summary
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.
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:
* Male and female patients who are ā„ 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)
Exclusion Criteria:
* 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)
What they're measuring
1
Satisfaction and Preference
Timeframe: Satisfaction and Preference ratings will be assessed during the only study visit: Visit 1/Day 1.