Optimizing Prosthetic Prescription to Mitigate the Effects of Perspiration

NCT ID: NCT07024342

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-04
• Study Completion Date: 2026-09-30

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.

Conditions

Amputation; Prosthesis User

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liner perforated with very small diameter holes

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

Group Type: EXPERIMENTAL

Liner perforated with very small diameter holes

Intervention Type: 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.

As-prescribed liner

Intervention Type: DEVICE

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

Liner perforated with somewhat larger diameter holes

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

Group Type: EXPERIMENTAL

Liner perforated with somewhat larger diameter holes

Intervention Type: 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.

As-prescribed liner

Intervention Type: DEVICE

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

Liner-liner

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

Group Type: EXPERIMENTAL

Liner-liner

Intervention Type: 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.

As-prescribed liner

Intervention Type: DEVICE

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

Interventions

Liner perforated with very small diameter holes

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.

Intervention Type: DEVICE

Liner perforated with somewhat larger diameter holes

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.

Intervention Type: DEVICE

Liner-liner

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.

Intervention Type: DEVICE

As-prescribed liner

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

Intervention Type: DEVICE

Other Intervention Names

SoftSkin Air S30; Uniprox, Zeulenroda-Triebes, GER; Silcare Breathe Cushion Liner; Endolite, Miamisburg, OH, USA; Liner-liner; Knit-Rite, Kansas City, KS, USA; Alpha Classic or Alpha Hybrid; WillowWood; Mt. Sterling, OH, USA

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Puget Sound Health Care System

FED

Sponsor Role: lead

Responsible Party

Glenn K. Klute, PhD

Research Career Scientist / Affiliate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Glenn K Klute, PhD

Role: PRINCIPAL_INVESTIGATOR

US Department of Veterans Affairs

Locations

VA Puget Sound Health Care System Seattle Division

Seattle, Washington, United States

Countries

United States

Other Identifiers

1588234

Identifier Type: -

Identifier Source: org_study_id