Adherence and Perspiration While Wearing Lower Limb Prostheses

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 17, 2019

Primary Completion Date

June 28, 2022

Study Completion Date

June 28, 2022

Conditions
Lower Extremity Amputation
Interventions
DEVICE

Dynamic Air Exchange - Rising Edge Design (DAE-RED)

The DAE-RED suspension system expels perspiration to the prosthesis exterior using a hybrid battery-powered pump and a body-weight activated pump. To use the DAE-RED, subjects will be fit with a modified patellar tendon-bearing socket that fits over a custom liner and sock. Up to four air intake ports are located proximally on the liner, approximately 25 mm superior to the socket brim. These ports incorporate a microvalve that allows air to flow into the liner-skin interstitial space while still maintaining a vacuum suspension. Distally, the pin lock has a 3-mm hole along its longitudinal axis that allows perspiration to be expelled into a distal reservoir. The prosthesis will also include: a standard aluminum pylon, pyramid adapters, and an Ossur Proflex XC prosthetic foot with Unity pump and foot cover.

DEVICE

Perforated elastomeric liner

The unique element of this perforated elastomeric liner are small perforations (\~0.3 mm diameter), uniformly distributed on a 4 x 5 mm grid, but with no perforations on the distal umbrella, that allow perspiration to be exuded into the liner-socket interstitial space. To use the perforated elastomeric liner, subjects will be fit with a modified patellar tendon-bearing socket that fits over a sock and the perforated elastomeric liner with a pin lock. The sock, worn between the socket and the liner, is used to absorb perspiration that is transported through the perforations in the liner. When needed for residual limb volume control, additional socks will be donned and included in tare weighing. The prosthesis will also include: a standard aluminum pylon, pyramid adapters, and an Ossur Proflex XC prosthetic foot and cosmesis.

DEVICE

As-prescribed prosthesis

The individual's as-prescribed suspension system is the prosthesis prescription that the patient and their clinical care team believes is the best prosthesis for their needs.

Trial Locations (1)

98108

VA Puget Sound Health Care System Seattle Division, Seattle

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Seattle Institute for Biomedical and Clinical Research

OTHER

NCT03900845 - Adherence and Perspiration While Wearing Lower Limb Prostheses | Biotech Hunter | Biotech Hunter