Liners for Prosthesis Users

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Puget Sound Health Care System

Disqualifiers: Ulcerated limb, Skin irritation, Osteoarthritis, Incarcerated, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different types of liners for individuals using a lower limb prosthesis. The goal is to determine which liner best reduces sweat while enhancing comfort, stability, and prosthesis retention. Participants will try liners with various hole sizes and compare them to their usual liner. This trial targets those with a below-knee amputation who use a prosthesis daily and experience sweating issues. As an unphased trial, it provides an opportunity to contribute to research that could enhance daily comfort and prosthesis use for many.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on prosthesis liners, so it's unlikely that your medications would be affected, but you should confirm with the trial organizers.

What prior data suggests that these liners are safe for prosthesis users?

Research shows that prosthetic liners can be safe and comfortable for users. These liners act as a cushion between the limb and the prosthetic, enhancing comfort and protecting the skin. They are generally well-tolerated and contribute to safer prosthesis use.

Studies have found that liners with larger holes allow sweat to escape, reducing skin problems and pain. This design helps keep the skin drier and healthier, which is important for long-term prosthetic use.

For liners with very small holes, research suggests they also allow sweat to pass through, keeping the skin dry. This makes the liner both practical and affordable, offering a good balance of function and comfort.

Overall, these liners aim to improve the experience for prosthesis users by addressing the common issue of sweating. They generally perform well without causing significant problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these prosthetic liners because they offer new ways to improve comfort and skin health for prosthesis users. Traditional liners often cause discomfort due to sweating and skin irritation, but these experimental liners feature unique perforation designs. The liner with very small diameter holes and the one with somewhat larger holes are designed to allow better airflow, potentially reducing moisture build-up and enhancing comfort during daily activities. The liner-liner approach also emphasizes improved fit and stability. By exploring these innovative designs, researchers aim to provide more comfortable and user-friendly options for people using prosthetics.

What evidence suggests that these liners are effective for improving stability, suspension, and comfort in prosthesis users?

This trial will compare different types of liners for prosthesis users. Research has shown that liners with tiny holes, known as perforated liners, benefit prosthetic users. Participants may receive a liner with very small diameter holes, allowing sweat to escape and keeping the skin healthier and more comfortable. Users of these liners report better skin health and less irritation. Another group will use liners with somewhat larger diameter holes, which also improve limb health and allow for normal prosthetic use. Both types of perforated liners show promise in enhancing comfort and health for prosthesis users. ^{1 2 4 5 6}

Who Is on the Research Team?

Glenn K Klute, PhD

Principal Investigator

US Department of Veterans Affairs

Are You a Good Fit for This Trial?

This trial is for lower limb prosthesis users who face issues with residual limb perspiration. Participants should be currently using a prescribed liner and willing to test different liners designed to improve comfort, stability, and suspension.

Inclusion Criteria

I have been using a prosthesis for at least six months.

Have, or will have access to a computer, tablet, or smartphone with video conferencing ability

Currently wear a WillowWood Alpha Classic or Alpha Hybrid liner

Exclusion Criteria

Pregnant

Currently incarcerated

My amputated limb has an open sore.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

A baseline measurement of the CLASS stability, suspension, and comfort scores is obtained upon enrollment

1 week

1 visit (in-person)

Treatment

Participants receive one of three study-provided liners and wear their prosthesis in their usual environments for two weeks

2 weeks

Participants wear liners at home, work, and community environments

Follow-up

Participants are monitored for changes in stability, suspension, and comfort after wearing the study-provided liner

2 weeks

1 visit (in-person) for follow-up assessment

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study compares three types of liners: one with larger holes, another with very small holes, and a double-layer liner against the standard as-prescribed liner. The goal is to see which type best mitigates sweat-related problems.

How Is the Trial Designed?

Group I: Liner-liner Experimental Treatment 2 Interventions

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

Group II: Liner perforated with very small diameter holes Experimental Treatment 2 Interventions

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

Group III: Liner perforated with somewhat larger diameter holes Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

VA Puget Sound Health Care System

Lead Sponsor

Trials

67

Recruited

225,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10443507/

The Influence of Perforated Prosthetic Liners on Residual ... These findings provide evidence that the use of perforated prosthetic liners allow improvements in residual limb health, while still permitting prosthetic use.

2. researchgate.net researchgate.net/publication/345911758_USING_PERFORATED_LINERS_TO_COMBAT_THE_DETRIMENTAL_EFFECTS_OF_EXCESSIVE_SWEATING_IN_LOWER_LIMB_PROSTHESIS_USERS

(PDF) Using Perforated Liners to Combat the Detrimental ... Results: Patients using the PL had healthier residual limbs, reporting higher scores on questions relating to limb health, experiencing fewer ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10443502/

Using Perforated Liners to Combat the Detrimental Effects ... The use of perforated liners shows much promise within prosthetic care, significantly improving the health of the residual limb.

4. jps.library.utoronto.ca jps.library.utoronto.ca/index.php/cpoj/article/view/34610

USING PERFORATED LINERS TO COMBAT THE ... The use of perforated liners shows much promise within prosthetic care, significantly improving the health of the residual limb.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2590093522000844

Material, design, and fabrication of custom prosthetic liners ... As a physical interface, a prosthetic liner is commonly used as a transition material between the residual limb and the stiff socket.

6. researchgate.net researchgate.net/publication/334852601_The_influence_of_perforated_prosthetic_liners_on_residual_limb_wound_healing_a_case_report

The Influence of Perforated Prosthetic Liners on Residual ... Perforated liners allow the transport of moisture away from the skin and allow negative pressure (a condition that has been shown to aid wound ...