Optimizing Prosthetic Prescription to Mitigate the Effects of Perspiration

NCT07024342 | Active Not Recruiting FDA Device

• 1 other identifier: 1588234
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation; Prosthesis User

Keywords

Lower limb prosthesis; perspiration; adherence

Outcome Measures

Primary Outcomes (3)

• Difference in CLASS stability score

  The Comprehensive Lower-limb Amputee Socket Survey (CLASS) is a self-report instrument that measures prosthesis stability, suspension, comfort, and appearance with very good internal consistency. The stability score measures how stable and balanced a person feels in their socket when they sit, stand, walk, and ascend or descend stairs.

  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

  The Comprehensive Lower-limb Amputee Socket Survey (CLASS) is a self-report instrument that measures prosthesis stability, suspension, comfort, and appearance with very good internal consistency. The suspension score measures how secure a person feels in their socket with no excessive movement when they sit, stand, walk, and ascend or descend stairs.

  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

  The Comprehensive Lower-limb Amputee Socket Survey (CLASS) is a self-report instrument that measures prosthesis stability, suspension, comfort, and appearance with very good internal consistency. The comfort score measures how comfortable a person feels in their socket when they sit, stand, walk, and ascend or descend stairs.

  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

Study Arms (3)

Liner perforated with very small diameter holes

EXPERIMENTAL

Subjects will wear their prosthesis in their home, work, and community environments while they will participate in their usual activities for two weeks.

Device: Liner perforated with very small diameter holes; Device: As-prescribed liner

Liner perforated with somewhat larger diameter holes

EXPERIMENTAL

Subjects will wear their prosthesis in their home, work, and community environments while they will participate in their usual activities for two weeks.

Device: Liner perforated with somewhat larger diameter holes; Device: As-prescribed liner

Liner-liner

EXPERIMENTAL

Subjects will wear their prosthesis in their home, work, and community environments while they will participate in their usual activities for two weeks.

Device: Liner-liner; Device: As-prescribed liner

Interventions

Liner perforated with somewhat larger diameter holes DEVICE

A commercially available, elastomeric liner perforated with somewhat larger holes (approximately 1.5 mm diameter) to allow perspiration to drain. This liner is worn between the skin and the participant's prosthetic socket.

Also known as: Silcare Breathe Cushion Liner; Endolite, Miamisburg, OH, USA

Liner perforated with somewhat larger diameter holes

Liner-liner DEVICE

A thin, special purpose half-ply sock which may reduce the effects of perspiration. The liner-liner is worn between the skin and the participant's as-prescribed liner.

Also known as: Liner-liner; Knit-Rite, Kansas City, KS, USA

Liner-liner

As-prescribed liner DEVICE

A commercially available, elastomeric liner with no perforations. This liner is worn between the skin and the participant's prosthetic socket.

Also known as: Alpha Classic or Alpha Hybrid; WillowWood; Mt. Sterling, OH, USA

Liner perforated with somewhat larger diameter holes; Liner perforated with very small diameter holes; Liner-liner

Liner perforated with very small diameter holes DEVICE

A commercially available, elastomeric liner perforated with very small holes (approximately 0.3 mm diameter) to allow perspiration to drain. This liner is worn between the skin and the participant's prosthetic socket.

Also known as: SoftSkin Air S30; Uniprox, Zeulenroda-Triebes, GER

Liner perforated with very small diameter holes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Puget Sound Health Care System: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division

Seattle, Washington, 98108, United States

Location

Study Officials

• Glenn K Klute, PhD

  US Department of Veterans Affairs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Career Scientist / Affiliate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 17, 2025
• Study Start: October 4, 2022
• Primary Completion: February 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within six months after publication of final study findings.
• Access Criteria: Open-source data repository (e.g., PubMed Central)

Locations

US (1)