Lower Extremity AmputationNCT03900845
Adherence and Perspiration While Wearing Lower Limb Prostheses
A study testing Dynamic Air Exchange - Rising Edge Design (DAE-RED), Perforated elastomeric liner and As-prescribed prosthesis in people with Lower Extremity Amputation, run by Seattle Institute for Biomedical and Clinical Research at 1 site in United States.
Trial summary
Individuals with lower limb amputation often complain about uncomfortable residual limb skin temperatures and the accumulation of sweat inside their prostheses. It doesn't take long before the presence of sweat on the residual limb leads to a lack of confidence in the security of their prosthetic suspension. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lower Extremity Amputation
- What is being tested?
- Dynamic Air Exchange - Rising Edge Design (DAE-RED), Perforated elastomeric liner and As-prescribed prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2019to 28 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 ours on an average day
- Ambulate without upper extremity aids
- Able to walk for 30 minutes on a treadmill
Who cannot join
- Improper fit and suspension with current prosthesis and one cannot be achieved with clinical resources (determined at initial visit)
- Current skin irritation or injury on residual limb
- Osteoarthritis, injury, or pain that interferes with walking ability
- Currently incarcerated
- Pregnant (determined via self-report)
- Inadequate cognitive function or language proficiency to consent to participate
- High (>20%) coronary heart disease risk at 10 years as determined by heir Framingham Risk Score
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
Official title: Novel Lower-Limb Prostheses: Comparing Adherence, Perspiration, and Residual Limb Skin Health in a Hot, Humid Environment and During Activities of Daily Living
Individuals with lower limb amputation often complain about uncomfortable residual limb skin temperatures and the accumulation of sweat inside their prostheses. It doesn't take long before the presence of sweat on the residual limb leads to a lack of confidence in the security of their prosthetic suspension. Some circumstances allow the wearer to doff the prosthesis before it falls off, wipe it and the residual limb dry, and then don it again. Another option is to simply reduce the intensity of activities before sweat becomes a problem. However, the Warfighter amputee may not be afforded such accommodations. For these service personnel, inadequate moisture management can significantly limit or inhibit their mobility. The objective of the proposed research is to provide lower limb amputees who work in demanding environments with a prosthesis that remains secure despite profuse residual limb sweating without compromising residual limb health and comfort.
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 adherence when worn in conditions that result in profuse sweating. The investigators also aim to compare how the three study prostheses effect residual limb skin health and comfort when participants pursue their usual activities in the home, work, and community environments.
To achieve these aims, the investigators will to recruit 25 below-knee amputees. Each subject will be asked to be asked to wear: (1) their as-prescribed prosthesis, (2) a prosthesis with a perforated elastomeric liner that allows sweat to flow away from the skin, and (3) a prosthesis that has a battery and body-weight activated pump to flow air between the prosthesis and the residual limb skin, allowing expulsion of any accumulated sweat. Subjects will wear each of these prostheses in the home, work, and community environments for two weeks, after which the investigators will measure their residual limb health and comfort. Subjects will then walk on a treadmill in a room whose climate will be set to Middle East-like conditions: 35 °C (95 °F) and 50% relative humidity. After 30 minutes, the investigators will measure any slippage of their prosthesis relative to their limb and how much sweat is expelled. The investigators hypothesize there will be differences in the amount of slippage, residual limb health, and comfort between the three prostheses.
Read the detailed description
Individuals with lower limb amputation often complain about uncomfortable residual limb skin temperatures, accumulation of perspiration inside their prostheses, and loss of confidence in suspension security that often leads them to cease their activities or, in demanding circumstances, may lead to their prosthesis falling off. Most amputees can sense the impending loss of suspension during vigorous activities and can stop, doff the prosthesis, wipe it and the residual limb dry, and then don it again. However, the Warfighter amputee may not be afforded such accommodations.
The investigators will compare the performance of an individual's as-prescribed suspension with two exciting alternatives: a new-to-market liner intended to transport perspiration away from the skin and an improved version of the Dynamic Air Exchange (DAE) suspension system the investigators developed. The new-to-market suspension system consists of a perforated elastomeric liner that allows perspiration to be exuded into the liner-prosthesis space. Anecdotal reports suggest this liner (Uniprox's SoftSkin Air), can maintain suspension during profuse perspiration, but may result in excessive skin dryness and discomfort. The improved Dynamic Air Exchange - Rising Edge Design (DAE-RED) suspension expels accumulated perspiration using a vacuum pump like its predecessor, but incorporates hybrid, body-weight activated pump to minimize battery consumption and a revised ventilation system obviating the need for undesirable exterior tube connections.
The objective of the proposed research is to provide lower limb amputees who work in demanding environments with a prosthesis that remains secure despite profuse residual limb perspiration without compromising residual limb health and comfort.
The proposed research has two specific aims: (1) compare three different, lower limb prosthetic suspension systems and identify which is most effective at maintaining a secure adherence when worn in conditions that result in profuse perspiration, and (2) compare how the three suspension systems effect residual limb skin health and comfort when participants pursue their usual activities in the home, work, and community environments.
The investigators will recruit unilateral transtibial amputees who are successful ambulators on their as-prescribed prosthesis and collect baseline data (residual limb skin hydration, transepidermal water loss (skin barrier function), and Socket Comfort Score). After fitting the participants with Uniprox and DAE-RED prostheses, subjects will wear one of these study prostheses (random order) for two weeks, after which the investigators will measure their skin hydration, transepidermal water loss, and Socket Comfort Score. The subject will then enter our environmental chamber (35° C and 50% relative humidity) and sit for a 30-minute acclimation period. The subject will then walk for 30 minutes on a treadmill at their self-selected speed. Subjects will then exit the environmental chamber and sit for 30 minutes in a comfortable climate (~20° C and 50% relative humidity). The amount of slippage, along with the perspiration accumulated/expelled, will be then be measured. Subjects will then be fit with their as-prescribed prosthesis and the protocol repeated to washout intervention effects. Finally, subjects will be fit with the other study prosthesis (either Uniprox or DAE-RED) and repeat the protocol.
After wearing the prostheses in our environmental chamber set to Middle East-like conditions (35 °C and 50% relative humidity), the investigators hypothesize:
H1.1 The amount of slippage (loss of adherence) will be different between the three suspension systems.
H1.2 The amount of perspiration expelled will be different between the Uniprox and DAE-RED.
After wearing the study prostheses in the home, work, and community environments for two weeks, the investigators hypothesize:
H2.1 Residual limb skin hydration will be different between the three suspension systems.
H2.2 Residual limb transepidermal water loss will be different between the three suspension systems.
H2.3 The Socket Comfort Score will be different between the three suspension systems.
- Conditions
- Lower Extremity Amputation
- Being tested
- Dynamic Air Exchange - Rising Edge Design (DAE-RED), Perforated elastomeric liner, As-prescribed prosthesis
- Keywords
- lower limb prosthesis, transtibial amputation, below knee amputation, adherence, perspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Air Exchange - Rising Edge Design (DAE-RED)Device
The DAE-RED suspension system expels perspiration to the prosthesis exterior using a hybrid battery-powered pump and a body-weight activated pump. To use the DAE-RED, subjects will be fit with a modified patellar tendon-bearing socket that fits over a custom liner and sock. Up to four air intake ports are located proximally on the liner, approximately 25 mm superior to the socket brim. These ports incorporate a microvalve that allows air to flow into the liner-skin interstitial space while still maintaining a vacuum suspension. Distally, the pin lock has a 3-mm hole along its longitudinal axis that allows perspiration to be expelled into a distal reservoir. The prosthesis will also include: a standard aluminum pylon, pyramid adapters, and an Ossur Proflex XC prosthetic foot with Unity pump and foot cover.
Perforated elastomeric linerDevice
Also called Uniprox Softskin Air prosthesis liner
The unique element of this perforated elastomeric liner are small perforations (~0.3 mm diameter), uniformly distributed on a 4 x 5 mm grid, but with no perforations on the distal umbrella, that allow perspiration to be exuded into the liner-socket interstitial space. To use the perforated elastomeric liner, subjects will be fit with a modified patellar tendon-bearing socket that fits over a sock and the perforated elastomeric liner with a pin lock. The sock, worn between the socket and the liner, is used to absorb perspiration that is transported through the perforations in the liner. When needed for residual limb volume control, additional socks will be donned and included in tare weighing. The prosthesis will also include: a standard aluminum pylon, pyramid adapters, and an Ossur Proflex XC prosthetic foot and cosmesis.
As-prescribed prosthesisDevice
The individual's as-prescribed suspension system is the prosthesis prescription that the patient and their clinical care team believes is the best prosthesis for their needs.
| Study group | Role | What they receive |
|---|---|---|
| Environmental Chamber | Experimental | All participants will wear all three study prostheses in an environmental chamber set at 35 degrees Celsius and 50% relative humidity. Receives: Device: Dynamic Air Exchange - Rising Edge Design (DAE-RED); Device: Perforated elastomeric liner; Device: As-prescribed prosthesis |
| Field Measurements | Experimental | All participants will wear all three study prostheses in their home, work, and community environments for two weeks. Receives: Device: Dynamic Air Exchange - Rising Edge Design (DAE-RED); Device: Perforated elastomeric liner; Device: As-prescribed prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
The amount of slippage (loss of adherence) will be determined by measuring the distance between a mark on the skin and the proximal border of the liner. Adherence will be measured in millimeters.
Measured: After the 90-minute rest-walk-rest protocol where subjects enter our environmental chamber for a 30-minute seated acclimation and a 30-minute treadmill walk and then exit the chamber for a 30-minute seated rest.
Expelled Perspiration
The amount of expelled perspiration will be determined by tare weight. Expelled perspiration will be measured in grams.
Measured: After the 90-minute rest-walk-rest protocol where subjects enter our environmental chamber for a 30-minute seated acclimation and a 30-minute treadmill walk and then exit the chamber for a 30-minute seated rest.
Secondary outcomes (3)
Skin Hydration
Skin hydration will be measured with a specialized instrument (Corneometer). A probe, acting as a capacitor, will apply an electric field to penetrate the skin (i.e., epidermis stratum corneum) on the posterior compartment of the residual limb to a depth of 10 to 20 μm. The amount of electrical charge stored by the capacitor is a function of skin hydration. Greater water content is proportional to higher capacitance, which is converted to converted to arbitrary units from 0 to 99. Skin hydration of less than 30 au is an indicator of very dry skin while greater than 40 au indicates sufficiently moisturized skin.
Measured: After wearing the study prosthesis in the home, work, and community environments for two weeks
Transepidermal Water Loss
Transepidermal water loss will be measured with a specialized instrument (Tewameter). A hollow cylinder probe with two pairs of sensors (temperature and relative humidity) will measure the density gradient of the water evaporation on the posterior compartment of the residual limb in units of g/m2/h. Transepidermal water loss between 10 and 15 g/h/m2 is an indicator of healthy skin. Transepidermal water loss of less than 10 g/h/m2 indicates very healthy skin.
Measured: After wearing the study prosthesis in the home, work, and community environments for two weeks
Satisfaction With the Prosthesis
An 11-point Likert scale will be used to record the subject's perception of satisfaction with the study prostheses. Participants will be asked to rate their satisfaction with the prosthesis on a 0 - 10 scale where 0 and 10 represent the least amount of satisfaction and the most amount of satisfaction imaginable, respectively. A higher score indicates a better outcome.
Measured: After wearing the study prosthesis in the home, work, and community environments 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 posted3 Apr 2019
- Study start17 Feb 2019
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lower Extremity 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
- Crossover
- Model description
- This study will use a within-subject crossover design to identify differences in adherence (slippage), expulsion of perspiration, residual limb health, and comfort that may exist between the three study prostheses. The three study prostheses include: (1) a perforated elastomeric liner intended to transport perspiration away from the residual limb, (2) a dynamic air exchange - rising edge design (DAE-RED) suspension system expels perspiration to the prosthesis exterior using a hybrid battery-powered pump and a body-weight activated pump that expels perspiration into a distal chamber, and (3) the participant's as-prescribed prosthesis. The order in which participants wear the perforated elastomeric liner and the DAE-RED systems will be randomized (first or third), but the as-prescribed prosthesis will always be worn second.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Glenn Klute, Seattle Institute for Biomedical and Clinical Research
- Investigators
- Glenn K Klute, PhD, Principal investigator, Dept. of Veterans Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900845
- Sponsor's protocol ID
- W81XWH-18-1-0559
- Other IDs
- CDMRP-OR170314
- Status last verified
- Jan 2026
- First submitted
- 29 Mar 2019
- Last updated
- 27 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Lower-Limb Prostheses: Comparing Adherence, Perspiration, and Residual Limb Skin Health in a Hot, Humid Environment and During Activities of Daily Living
- ClinicalTrials.gov ID
- NCT03900845
- Acronym / sponsor ID
- W81XWH-18-1-0559
- Conditions
- Lower Extremity Amputation
- Keywords
- lower limb prosthesis, transtibial amputation, below knee amputation, adherence, perspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 17 Feb 2019 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Posted 27 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals with lower limb amputation often complain about uncomfortable residual limb skin temperatures and the accumulation of sweat inside their prostheses. It doesn't take long before the presence of sweat on the residual limb leads to a lack of confidence in the security of their prosthetic suspension. Some circumstances allow the wearer to doff the prosthesis before it falls off, wipe it and the residual limb dry, and then don it again. Another option is to simply reduce the intensity of activities before sweat becomes a problem. However, the Warfighter amputee may not be afforded such accommodations. For these service personnel, inadequate moisture management can significantly limit or inhibit their mobility. The objective of the proposed research is to provide lower limb amputees who work in demanding environments with a prosthesis that remains secure despite profuse residual limb sweating without compromising residual limb health and comfort.
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 adherence when worn in conditions that result in profuse sweating. The investigators also aim to compare how the three study prostheses effect residual limb skin health and comfort when participants pursue their usual activities in the home, work, and community environments.
To achieve these aims, the investigators will to recruit 25 below-knee amputees. Each subject will be asked to be asked to wear: (1) their as-prescribed prosthesis, (2) a prosthesis with a perforated elastomeric liner that allows sweat to flow away from the skin, and (3) a prosthesis that has a battery and body-weight activated pump to flow air between the prosthesis and the residual limb skin, allowing expulsion of any accumulated sweat. Subjects will wear each of these prostheses in the home, work, and community environments for two weeks, after which the investigators will measure their residual limb health and comfort. Subjects will then walk on a treadmill in a room whose climate will be set to Middle East-like conditions: 35 °C (95 °F) and 50% relative humidity. After 30 minutes, the investigators will measure any slippage of their prosthesis relative to their limb and how much sweat is expelled. The investigators hypothesize there will be differences in the amount of slippage, residual limb health, and comfort between the three prostheses.
Detailed description
Individuals with lower limb amputation often complain about uncomfortable residual limb skin temperatures, accumulation of perspiration inside their prostheses, and loss of confidence in suspension security that often leads them to cease their activities or, in demanding circumstances, may lead to their prosthesis falling off. Most amputees can sense the impending loss of suspension during vigorous activities and can stop, doff the prosthesis, wipe it and the residual limb dry, and then don it again. However, the Warfighter amputee may not be afforded such accommodations.
The investigators will compare the performance of an individual's as-prescribed suspension with two exciting alternatives: a new-to-market liner intended to transport perspiration away from the skin and an improved version of the Dynamic Air Exchange (DAE) suspension system the investigators developed. The new-to-market suspension system consists of a perforated elastomeric liner that allows perspiration to be exuded into the liner-prosthesis space. Anecdotal reports suggest this liner (Uniprox's SoftSkin Air), can maintain suspension during profuse perspiration, but may result in excessive skin dryness and discomfort. The improved Dynamic Air Exchange - Rising Edge Design (DAE-RED) suspension expels accumulated perspiration using a vacuum pump like its predecessor, but incorporates hybrid, body-weight activated pump to minimize battery consumption and a revised ventilation system obviating the need for undesirable exterior tube connections.
The objective of the proposed research is to provide lower limb amputees who work in demanding environments with a prosthesis that remains secure despite profuse residual limb perspiration without compromising residual limb health and comfort.
The proposed research has two specific aims: (1) compare three different, lower limb prosthetic suspension systems and identify which is most effective at maintaining a secure adherence when worn in conditions that result in profuse perspiration, and (2) compare how the three suspension systems effect residual limb skin health and comfort when participants pursue their usual activities in the home, work, and community environments.
The investigators will recruit unilateral transtibial amputees who are successful ambulators on their as-prescribed prosthesis and collect baseline data (residual limb skin hydration, transepidermal water loss (skin barrier function), and Socket Comfort Score). After fitting the participants with Uniprox and DAE-RED prostheses, subjects will wear one of these study prostheses (random order) for two weeks, after which the investigators will measure their skin hydration, transepidermal water loss, and Socket Comfort Score. The subject will then enter our environmental chamber (35° C and 50% relative humidity) and sit for a 30-minute acclimation period. The subject will then walk for 30 minutes on a treadmill at their self-selected speed. Subjects will then exit the environmental chamber and sit for 30 minutes in a comfortable climate (~20° C and 50% relative humidity). The amount of slippage, along with the perspiration accumulated/expelled, will be then be measured. Subjects will then be fit with their as-prescribed prosthesis and the protocol repeated to washout intervention effects. Finally, subjects will be fit with the other study prosthesis (either Uniprox or DAE-RED) and repeat the protocol.
After wearing the prostheses in our environmental chamber set to Middle East-like conditions (35 °C and 50% relative humidity), the investigators hypothesize:
H1.1 The amount of slippage (loss of adherence) will be different between the three suspension systems.
H1.2 The amount of perspiration expelled will be different between the Uniprox and DAE-RED.
After wearing the study prostheses in the home, work, and community environments for two weeks, the investigators hypothesize:
H2.1 Residual limb skin hydration will be different between the three suspension systems.
H2.2 Residual limb transepidermal water loss will be different between the three suspension systems.
H2.3 The Socket Comfort Score will be different between the three suspension systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will use a within-subject crossover design to identify differences in adherence (slippage), expulsion of perspiration, residual limb health, and comfort that may exist between the three study prostheses. The three study prostheses include: (1) a perforated elastomeric liner intended to transport perspiration away from the residual limb, (2) a dynamic air exchange - rising edge design (DAE-RED) suspension system expels perspiration to the prosthesis exterior using a hybrid battery-powered pump and a body-weight activated pump that expels perspiration into a distal chamber, and (3) the participant's as-prescribed prosthesis. The order in which participants wear the perforated elastomeric liner and the DAE-RED systems will be randomized (first or third), but the as-prescribed prosthesis will always be worn second.
| Arm | Type | Receives |
|---|---|---|
| Environmental Chamber | Experimental | Device: Dynamic Air Exchange - Rising Edge Design (DAE-RED), Device: Perforated elastomeric liner, Device: As-prescribed prosthesisAll participants will wear all three study prostheses in an environmental chamber set at 35 degrees Celsius and 50% relative humidity. |
| Field Measurements | Experimental | Device: Dynamic Air Exchange - Rising Edge Design (DAE-RED), Device: Perforated elastomeric liner, Device: As-prescribed prosthesisAll participants will wear all three study prostheses in their home, work, and community environments 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 (5 listed)
- Unilateral transtibial amputation
- Been fit with a prosthesis and used it for at least six months
- Wear the prosthesis for four or more ours on an average day
- Ambulate without upper extremity aids
- Able to walk for 30 minutes on a treadmill
Key exclusion criteria (7 listed)
- Improper fit and suspension with current prosthesis and one cannot be achieved with clinical resources (determined at initial visit)
- Current skin irritation or injury on residual limb
- Osteoarthritis, injury, or pain that interferes with walking ability
- Currently incarcerated
- Pregnant (determined via self-report)
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 |
|---|---|---|
| Dynamic Air Exchange - Rising Edge Design (DAE-RED)The DAE-RED suspension system expels perspiration to the prosthesis exterior using a hybrid battery-powered pump and a body-weight activated pump. To use the DAE-RED, subjects will be fit with a modified patellar tendon-bearing socket that fits over a custom liner and sock. Up to four air intake ports are located proximally on the liner, approximately 25 mm superior to the socket brim. These ports incorporate a microvalve that allows air to flow into the liner-skin interstitial space while still maintaining a vacuum suspension. Distally, the pin lock has a 3-mm hole along its longitudinal axis that allows perspiration to be expelled into a distal reservoir. The prosthesis will also include: a standard aluminum pylon, pyramid adapters, and an Ossur Proflex XC prosthetic foot with Unity pump and foot cover. | Device | Environmental Chamber, Field Measurements |
| Perforated elastomeric linerAlso: Uniprox Softskin Air prosthesis linerThe unique element of this perforated elastomeric liner are small perforations (~0.3 mm diameter), uniformly distributed on a 4 x 5 mm grid, but with no perforations on the distal umbrella, that allow perspiration to be exuded into the liner-socket interstitial space. To use the perforated elastomeric liner, subjects will be fit with a modified patellar tendon-bearing socket that fits over a sock and the perforated elastomeric liner with a pin lock. The sock, worn between the socket and the liner, is used to absorb perspiration that is transported through the perforations in the liner. When needed for residual limb volume control, additional socks will be donned and included in tare weighing. The prosthesis will also include: a standard aluminum pylon, pyramid adapters, and an Ossur Proflex XC prosthetic foot and cosmesis. | Device | Environmental Chamber, Field Measurements |
| As-prescribed prosthesisThe individual's as-prescribed suspension system is the prosthesis prescription that the patient and their clinical care team believes is the best prosthesis for their needs. | Device | Environmental Chamber, Field Measurements |
Primary outcome
Adherence
Time frame: After the 90-minute rest-walk-rest protocol where subjects enter our environmental chamber for a 30-minute seated acclimation and a 30-minute treadmill walk and then exit the chamber for a 30-minute seated rest.
The amount of slippage (loss of adherence) will be determined by measuring the distance between a mark on the skin and the proximal border of the liner. Adherence will be measured in millimeters.
Expelled Perspiration
Time frame: After the 90-minute rest-walk-rest protocol where subjects enter our environmental chamber for a 30-minute seated acclimation and a 30-minute treadmill walk and then exit the chamber for a 30-minute seated rest.
The amount of expelled perspiration will be determined by tare weight. Expelled perspiration will be measured in grams.
3 secondary outcomes
Skin Hydration
Time frame: After wearing the study prosthesis in the home, work, and community environments for two weeks
Transepidermal Water Loss
Time frame: After wearing the study prosthesis in the home, work, and community environments for two weeks
Satisfaction With the Prosthesis
Time frame: After wearing the study prosthesis in the home, work, and community environments for two weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
Dept. 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 Dynamic Air Exchange - Rising Edge Design (DAE-RED), Perforated elastomeric liner and As-prescribed prosthesis in people with Lower Extremity Amputation, run by Seattle Institute for Biomedical and Clinical Research 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 5 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: finished, as of the sponsor's last update on 27 Jan 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?
Yes. Results are posted in the registry (first posted 27 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adherence (time frame: After the 90-minute rest-walk-rest protocol where subjects enter our environmental chamber for a 30-minute seated acclimation and a 30-minute treadmill walk and then exit the chamber for a 30-minute seated rest.). The study lists 2 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 27 Jan 2026.