Study design
The clinical pilot study was a randomized, controlled, open label, cross-over study design with the endpoints of relative humidity (RH), perceived sweat, stability, comfort, and suspension. All participants were fitted to the vented investigational device at SRT National Prosthetic Center, Indianapolis, USA. All other study related activities occurred at Indiana University School of Medicine, Indianapolis, IN. After a minimum of two weeks of adaptation time, participants were randomized to two arms of this study: (a) Interventional device arm: a vented investigational device (AeroFit™ socket and liner), Össur (VS); and (b) SoC or comparator device arm: Seal-In® silicone liner and the AeroFit Socket with sealed vents, Össur (nVS). The relative humidity and temperature sensors were placed at the soft tissue on residual limb thigh and sound leg thigh (Fig. 1-1a, 1-1b). One additional sensor was placed on the environment. Breathable self-adhesive tape (Hypafix, BSN Medical, Germany) was used to affix the sensors and positioned the sensor head properly. RH and temperature in the skin/liner interface were measured throughout the entire study procedures as presented (Fig. 1-2c, 1-2d). The procedure started in a regular temperature room (21 °C ± 2 degrees) with a 10-min resting period with no prosthesis on for a baseline measurement. Then another 10-min resting period with only the liner on and 10 min with the liner and socket on. After resting, the subjects moved to a heated (28 °C ± 2 degrees) and humidity (42% ± 2%) controlled room where they walked at a self-selected speed on a treadmill for 20 min wearing the MSR Data Logger and sensor system (Fig. 1-1b). After 10 min resting, subjects left the heated room, entered the normal temperature room, performed the FSST and walked stairs. At last, patient-reported outcomes (perceived sweat and CLASS