Prosthetic Suspension Systems for Lower Limb Prosthesis Wearers

Overseen By Elise Campbell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Institute for Biomedical and Clinical Research

Disqualifiers: Skin irritation, Osteoarthritis, Pregnancy, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best prosthetic suspension system for lower limb amputees who often face sweat-related issues. Researchers will test three different systems to determine which remains secure and maintains skin health and comfort, even in hot and sweaty conditions. Participants will use their usual prosthesis (as-prescribed prosthesis), one with a special liner to manage sweat (perforated elastomeric liner), and another with a pump system for airflow (Dynamic Air Exchange - Rising Edge Design, or DAE-RED). The trial seeks individuals with a below-knee amputation who have used their prosthesis regularly for at least six months and can walk on a treadmill for 30 minutes.

As an unphased trial, this study provides participants the chance to contribute to significant research that could enhance comfort and quality of life for many amputees.

Do I need to stop taking my current medications for this trial?

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

What prior data suggests that these prosthetic suspension systems are safe for lower limb amputees?

A previous study demonstrated that the Dynamic Air Exchange - Rising Edge Design (DAE-RED) prosthetic system effectively removes moisture from the prosthetic socket, keeping the skin dry without significantly altering skin temperature. This feature is important for comfort and preventing skin issues.

Research indicates that the perforated elastomeric liner could improve the health of the skin on the residual limb. This liner allows sweat to flow away, potentially making the prosthesis more comfortable over time.

Both systems are designed to manage sweat and keep the prosthesis secure, which could be especially beneficial in hot, humid environments. Tests in various conditions have shown positive results in managing sweat and skin health, confirming the safety and comfort of these prostheses.

For those considering joining a trial for these prosthetic systems, existing research suggests they are safe to try and can potentially enhance comfort and skin health without adverse effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative prosthetic suspension systems for lower limb prosthesis wearers. The Dynamic Air Exchange - Rising Edge Design (DAE-RED) is unique in its approach, as it actively manages airflow and pressure within the prosthetic socket, potentially improving comfort and reducing skin issues. Another standout is the perforated elastomeric liner, which enhances breathability and moisture control, offering a cooler and more comfortable experience in warm conditions. By testing these designs in both controlled and real-world environments, the trial aims to uncover how these new technologies can improve daily life for prosthesis users.

What evidence suggests that this trial's prosthetic suspension systems could be effective for lower limb amputees?

This trial will evaluate three prosthetic suspension systems: the Dynamic Air Exchange - Rising Edge Design (DAE-RED), the perforated elastomeric liner, and the as-prescribed prosthesis. Studies have shown that prosthetic systems with a dynamic air exchange (DAE) design effectively reduce sweat, enhancing comfort and security for users. This system allows air to flow and removes sweat, keeping the prosthesis in place even in hot conditions. Research indicates that perforated elastomeric liners are also beneficial. These liners allow sweat to escape, promoting healthier and more comfortable skin. Patients using these liners often report less sweating and improved skin condition. Both systems aim to address the common issue of sweat buildup in prosthetics, enhancing overall comfort and fit for users. ^{1 4 6 7 8}

Who Is on the Research Team?

Glenn K Klute, PhD

Principal Investigator

Dept. of Veterans Affairs

Are You a Good Fit for This Trial?

This trial is for individuals with a single below-knee amputation who have been using their prescribed prosthesis for at least six months. They must be able to walk without hand support and use the prosthesis daily for more than four hours. Excluded are those with cognitive or language barriers, high heart disease risk, ill-fitting prostheses that can't be adjusted, current incarceration, pregnancy, skin issues on the limb, or walking impairments due to other conditions.

Inclusion Criteria

I can walk without using my arms for support.

I can walk for 30 minutes on a treadmill.

I wear my prosthesis for at least 4 hours daily.

Exclusion Criteria

My risk of heart disease in the next 10 years is high.

Inadequate cognitive function or language proficiency to consent to participate

Improper fit and suspension with current prosthesis and one cannot be achieved with clinical resources (determined at initial visit)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Field Measurements

Participants wear each of the three study prostheses in their home, work, and community environments to assess skin health and comfort

6 weeks

3 visits (in-person) for prosthesis fitting and data collection

Environmental Chamber Testing

Participants wear each prosthesis in a controlled environment to measure perspiration expulsion and adherence

90 minutes per session

3 visits (in-person) for environmental chamber testing

Follow-up

Participants are monitored for any long-term effects on skin health and prosthesis satisfaction

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• As-prescribed prosthesis
• Dynamic Air Exchange - Rising Edge Design (DAE-RED)
• Perforated elastomeric liner

Trial Overview

The study compares three lower limb prosthetic suspension systems: (1) standard prescribed prosthesis; (2) one with a perforated liner allowing sweat drainage; and (3) another featuring an air pump system expelling sweat. Participants will wear each type in various environments and undergo tests to measure slippage and comfort under simulated Middle East climate conditions.

How Is the Trial Designed?

Group I: Field Measurements Experimental Treatment 3 Interventions

All participants will wear all three study prostheses in their home, work, and community environments for two weeks.

Group II: Environmental Chamber Experimental Treatment 3 Interventions

All participants will wear all three study prostheses in an environmental chamber set at 35 degrees Celsius and 50% relative humidity.

Who Is Running the Clinical Trial?

Seattle Institute for Biomedical and Clinical Research

Lead Sponsor

Trials

55

Recruited

13,700+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03900845

Adherence and Perspiration While Wearing Lower Limb ...

The aim of this research is to compare three different, lower limb prosthetic suspension systems and identify which is most effective at maintaining a secure ...

2.

apps.dtic.mil

apps.dtic.mil/sti/trecms/pdf/AD1225084.pdf

W81XWH-18-1-0559 TITLE: Novel Lower-Limb Prostheses

The DAE-RED prosthetic components were delivered to the VA site for final assembly and human subject testing, meeting the recurring milestone for Major Task 1 ...

3.

digital.lib.washington.edu

digital.lib.washington.edu/bitstreams/7c3e6b08-e991-4b5a-ac2a-18d322a3a4ce/download

1 Dynamic Air Exchange Prosthesis: Effects on Heat Transfer ...

Lower limb amputees are often dissatisfied with the comfort of their prosthesis. A literature review of 38 selected studies revealed that more than 53% of ...

4.

apps.dtic.mil

apps.dtic.mil/sti/trecms/pdf/AD1054770.pdf

Perspiration Thresholds and Secure Suspension for Lower Limb ...

The results ... prosthesis with an innovative prosthesis that uses dynamic air exchange to expel accumulated perspiration. ... The dynamic air exchange system has ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7443051/

Effectiveness of Elevated Vacuum and Suction Prosthetic ...

Research assessing the effectiveness of EV in managing residual limb volume has shown inconsistent results when compared to other suspension methods such as ...

6.

accessdata.fda.gov

accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=71&submission_type_id=&devicename=&productcode=&deviceclass=&thirdparty=&panel=&regulationnumber=890&implant_flag=&life_sustain_support_flag=&summary_malfunction_reporting=&pagenum=10&sortcolumn=RegulationNumber

Product Classification - FDA

External limb prosthetic component. 890.342016, 1. IRA. hand, external limb component, mechanical, External limb prosthetic component ...

7.

accessdata.fda.gov

accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=166&submission_type_id=&devicename=&productcode=&deviceclass=1&thirdparty=&panel=&regulationnumber=&implant_flag=&life_sustain_support_flag=&summary_malfunction_reporting=&pagenum=5&sortcolumn=RegulationNumberDESC

Product Classification - FDA

Product Classification ; ISN. cable, External limb prosthetic component. 890.3420 ; ISP. valve, prosthesis, External limb prosthetic component ...

8.

digital.lib.washington.edu

digital.lib.washington.edu/researchworks/items/019ca1e7-663a-4459-8927-c935d1722d50

Dynamic Air Exchange Prosthesis: Effects on Heat Transfer ...

The DAE system removes moisture from the socket effectively but has little effect on overall skin temperature. The computational model suggests that cooling ...