Trial Outcomes & Findings for IceExplore TF Liner Alpha Investigation (NCT NCT04787484)

There were 18 enrolled in total and then there were two dropouts.

The Comprehensive Lower Limb Amputee Socket Survey (CLASS) is a patient-reported outcome measure designed to assess satisfaction with a prosthetic socket across four domains: suspension, stability, comfort, and appearance. Items are rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with 0 indicating that an item is not applicable. In this study, the CLASS Suspension subscale was used to evaluate participants' perceived security of prosthetic suspension. Participants rated the security of suspension during four activities: sitting, standing, walking, and ascending or descending stairs. The ratings for all activities were summed and divided by 16, the maximum possible score, to generate a normalized suspension score, with higher scores indicating greater perceived suspension security. The resulting value was multiplied by 100 and reported as a percentage score ranging from 25-100, where higher scores indicate better perceived suspension.

PEQ item Q is one question from Prosthetic Evaluation Questionnaire (PEQ) - "Over the past four weeks rate how much you sweat inside your prosthesis (in the sock, liner, socket)". A self-reported measure on a scale from 1-10 were 1 is extreme amount of sweat and 10 is no sweat at all.

PEQ Residual Limb Health (PEQ-RLH) is a set of 6 questions. The scale has been validated for internal consistency and temporal stability. The questions are self-reported on a scale 1-10 about sweat, smell, swollen limb, rashes, ingrown hairs and blisters or sores. Participants rated each item on a 10-point Likert scale, where higher scores indicated better residual limb health and fewer skin-related problems. The overall PEQ-RLH score was calculated as the mean of the six item scores

The Comprehensive Lower Limb Amputee Socket Survey (CLASS) is a patient-reported outcome measure designed to assess satisfaction with a prosthetic socket across four domains: suspension, stability, comfort, and appearance. Items are rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with 0 indicating that an item is not applicable. In this study, the CLASS Comfort subscale was used to evaluate participants' perceived security of prosthetic suspension. Participants rated the socket comfort during four activities: sitting, standing, walking, and ascending or descending stairs. The ratings for all activities were summed and divided by 16, the maximum possible score, to generate a normalized comfort score, with higher scores indicating greater perceived suspension security. The resulting value was multiplied by 100 and reported as a percentage score ranging from 25-100, where higher scores indicate better perceived comfort.

Perceived stability during increased perspiration, an in-house developed self-report measure on the scale from 1-10, higher number corresponds with a more positive response, more stability. "When experiencing increased perspiration, during activities of daily living, I feel stable in the socket".

Perceived suspension during increased perspiration, an in-house developed self-report measure on the scale from 1-10, higher number corresponds with a more positive response, better suspension. "When experiencing increased perspiration, during activities of daily living, suspension between my residual limb and liner feels".

Perceived hygiene evaluated with Prosthetic Evaluation Questionnaire, item R (Over the past 4 weeks rate how smelly your prosthesis was at its worst. A self-reported measure on a scale from 1-10 were 1 is extremely smelly and 10 is no at all smelly.