Clinical trial NCT07024342: Optimizing Prosthetic Prescription to Mitigate the Effects of Perspiration
Official title: Optimizing Prosthetic Prescription to Mitigate the Effects of Perspiration
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Amputation
Prosthesis User
Keywords: Lower limb prosthesis
perspiration
adherence
Lead sponsor: VA Puget Sound Health Care System
Sponsor class: FED
First posted: 2025-06-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A between-subjects, repeated measures experiment will be conducted with individuals with unilateral transtibial limb loss (n=180) who are successful ambulators and have issues with perspiration by self-report. Baseline measurements will be obtained at the time of enrollment while participants are wearing their as-prescribed liner. After wearing the randomly assigned study intervention for two weeks, measurements will be repeated.
Primary purpose: TREATMENT

Brief summary: The specific aim of this research is to compare three clinically available liners, each intended to address problems of residual limb perspiration, with the as-prescribed liner of lower limb prosthesis user and determine their effect on stability, suspension, and comfort.

Detailed description: The objective of the proposed research is to provide the individual with a below-knee amputation a prosthesis that best addresses problems of perspiration and its accumulation inside the prosthesis. A concern of every individual with a lower limb prosthesis is keeping their residual limb healthy and injury free. Naturally occurring perspiration, induced by moderate to vigorous activity or hot and humid environments, leads to perspiration. While the modern prosthetic liner can be stable, secure, and comfortable when dry, the materials from which they are made trap heat and are impermeable to moisture. When perspiration accumulation is a frequent occurrence, a host of biomechanical and skin problems can arise. Clinicians have few available options to prevent perspiration accumulation inside the prosthesis.

For individuals who do have problems with residual limb perspiration, some may be able to stop their activity when it accumulates, remove their prosthesis, dry it and their residual limb, then don it again and carry on. Others, like the military service personnel, may not have such an opportunity. These individuals can be prescribed a perforated liner through which perspiration can drain, or a thin, special purpose half-ply sock worn between the skin and liner, which can reduce the lubricating effects of perspiration. Current commercially-available perforated liners come with two different sized holes: one with small holes the size of a pinprick, and one with somewhat larger holes the size of a pinhead. There is little evidence available to suggest which of the three approaches is best.

The aim of the proposed research is to compare these three clinically-available options and determine which is best at addressing the problem of perspiration accumulation inside the prosthesis. To achieve this aim, we propose to recruit 180 individuals with below-knee amputations to participate in a human subject experiment. Upon enrollment, we will administer a survey to measure the stability, suspension, and comfort of their socket. Subjects will then receive one of three study-provided liners: (1) a liner-liner, (2) a liner perforated with very small diameter holes, or (3) a liner perforated with somewhat larger diameter holes. After subjects have worn the study-provided liner for two weeks, we will administer the survey again. The results of this research will identify which of the three clinically-available options is best at addressing the problem of perspiration accumulation inside the prosthesis.

More than half a million Americans live with a lower limb amputation, and a few thousand of these were on active duty when it happened. For the many individuals with a lower limb amputation who have problems with perspiration, the results of this two-year study will be of value as it will help them, and their clinicians, choose the best commercially-available solution.

Eligibility criteria: Inclusion Criteria:

* Unilateral transtibial amputation
* Been fit with a prosthesis and used it for at least six months
* Wear the prosthesis for four or more hours on average per day
* Have, or will have access to a computer, tablet, or smartphone with video conferencing ability
* Currently have problems with residual limb perspiration
* Currently wear a WillowWood Alpha Classic or Alpha Hybrid liner

Exclusion Criteria:

* Improper fit and suspension with current prosthesis and one cannot be achieved with clinical resources
* Residual limb is ulcerated
* Current skin irritation or injury on residual limb
* Osteoarthritis, injury, or pain that interferes with walking ability
* Currently incarcerated
* Pregnant
* Inadequate cognitive function or language proficiency to consent to participate

Primary outcomes:
measure: Difference in CLASS stability score
timeFrame: A baseline measurement of the CLASS stability score will be obtained upon enrollment and repeated after the subject has worn one of the study-provided liners for two weeks
measure: Difference in CLASS suspension score
timeFrame: A baseline measurement of the CLASS suspension score will be obtained upon enrollment and repeated after the subject has worn one of the study-provided liners for two weeks
measure: Difference in CLASS comfort score
timeFrame: A baseline measurement of the CLASS comfort score will be obtained upon enrollment and repeated after the subject has worn one of the study-provided liners for two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division
state: Washington
Study officials:
affiliation: US Department of Veterans Affairs
name: Glenn K Klute, PhD
role: PRINCIPAL_INVESTIGATOR
References: