Active — Not RecruitingNot Applicable

Optimizing Prosthetic Prescription to Mitigate the Effects of Perspiration

United States180 participantsStarted 2022-10-04

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

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

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

Trial details

NCT IDNCT07024342

SponsorVA Puget Sound Health Care System

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2026-02

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