AmputationNCT07024342
Optimizing Prosthetic Prescription to Mitigate the Effects of Perspiration
A study testing Liner perforated with very small diameter holes, Liner perforated with somewhat larger diameter holes and Liner-liner in people with Amputation and Prosthesis User, run by VA Puget Sound Health Care System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Amputation, Prosthesis User
- What is being tested?
- Liner perforated with very small diameter holes, Liner perforated with somewhat larger diameter holes and Liner-liner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2022to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division
Seattle, Washington, 98108
About this study
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.
Read the 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
- Being tested
- Liner perforated with very small diameter holes, Liner perforated with somewhat larger diameter holes, Liner-liner, As-prescribed liner
- Keywords
- Lower limb prosthesis, perspiration, adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liner perforated with very small diameter holesDevice
Also called SoftSkin Air S30; Uniprox, Zeulenroda-Triebes, GER
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.
Liner perforated with somewhat larger diameter holesDevice
Also called Silcare Breathe Cushion Liner; Endolite, Miamisburg, OH, USA
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.
Liner-linerDevice
Also called Liner-liner; Knit-Rite, Kansas City, KS, USA
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 linerDevice
Also called Alpha Classic or Alpha Hybrid; WillowWood; Mt. Sterling, OH, USA
A commercially available, elastomeric liner with no perforations. This liner is worn between the skin and the participant's prosthetic socket.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Liner-liner; Device: As-prescribed liner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start4 Oct 2022
- Primary completion1 Feb 2026
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Puget Sound Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Glenn K. Klute, PhD, VA Puget Sound Health Care System
- Investigators
- Glenn K Klute, PhD, Principal investigator, US Department of Veterans Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024342
- Sponsor's protocol ID
- 1588234
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2022
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: A de-identified, anonymized dataset in machine-readable format will be created and shared for all individual participant data (IPD) that underlie results in a publication. The investigators will follow 164.514(a) of the HIPAA Privacy Rule for de-identification of IPD.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Prosthetic Prescription to Mitigate the Effects of Perspiration
- ClinicalTrials.gov ID
- NCT07024342
- Acronym / sponsor ID
- 1588234
- Conditions
- Amputation, Prosthesis User
- Keywords
- Lower limb prosthesis, perspiration, adherence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- VA Puget Sound Health Care SystemUS federal agency
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Liner perforated with very small diameter holes | Experimental | Device: Liner perforated with very small diameter holes, Device: As-prescribed linerSubjects will wear their prosthesis in their home, work, and community environments while they will participate in their usual activities for two weeks. |
| Liner perforated with somewhat larger diameter holes | Experimental | Device: Liner perforated with somewhat larger diameter holes, Device: As-prescribed linerSubjects will wear their prosthesis in their home, work, and community environments while they will participate in their usual activities for two weeks. |
| Liner-liner | Experimental | Device: Liner-liner, Device: As-prescribed linerSubjects will wear their prosthesis in their home, work, and community environments while they will participate in their usual activities for two weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liner perforated with very small diameter holesAlso: SoftSkin Air S30; Uniprox, Zeulenroda-Triebes, GERA 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. | Device | Liner perforated with very small diameter holes |
| Liner perforated with somewhat larger diameter holesAlso: Silcare Breathe Cushion Liner; Endolite, Miamisburg, OH, USAA 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. | Device | Liner perforated with somewhat larger diameter holes |
| Liner-linerAlso: Liner-liner; Knit-Rite, Kansas City, KS, USAA 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. | Device | Liner-liner |
| As-prescribed linerAlso: Alpha Classic or Alpha Hybrid; WillowWood; Mt. Sterling, OH, USAA commercially available, elastomeric liner with no perforations. This liner is worn between the skin and the participant's prosthetic socket. | Device | Liner perforated with somewhat larger diameter holes, Liner perforated with very small diameter holes, Liner-liner |
Primary outcome
Difference in CLASS stability score
Time frame: 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
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.
Difference in CLASS suspension score
Time frame: 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
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.
Difference in CLASS comfort score
Time frame: 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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset in machine-readable format will be created and shared for all individual participant data (IPD) that underlie results in a publication. The investigators will follow 164.514(a) of the HIPAA Privacy Rule for de-identification of IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn K Klute, PhD principal investigator
US Department of Veterans Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liner perforated with very small diameter holes, Liner perforated with somewhat larger diameter holes and Liner-liner in people with Amputation and Prosthesis User, run by VA Puget Sound Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in CLASS stability score (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.