Trial Outcomes & Findings for Adherence and Perspiration While Wearing Lower Limb Prostheses (NCT NCT03900845)
NCT ID: NCT03900845
Last Updated: 2026-01-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
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.
Results posted on
2026-01-27
Participant Flow
Recruitment of participants was performed at a US Veterans Hospital.
Twenty eligible individuals (17 male, 3 female) were enrolled in the study. All considered themselves moderately active community ambulators. Twelve individuals terminated before randomization: one withdrew due to health issues, one did not feel strong enough to complete the protocol, one left the country, five had prosthetic fitting issues, and four were lost to follow up after consent.
Participant milestones
| Measure |
PERF, Then RX, Then DAE-RED
A within-subject crossover experiment was conducted to determine if differences in adherence (slippage), expulsion of perspiration, residual limb health, and comfort exist between three study suspension systems. The three suspension systems included: (1) a perforated elastomeric liner (PERF) liner intended to transport perspiration away from the residual limb, (2) a Dynamic Air Exchange - Rising Edge Design (DAE-RED) suspension system that expels perspiration to the prosthesis exterior using a hybrid battery and body weight actuated vacuum pumps, and (3) the participant's as-prescribed (RX) prosthesis. The order in which participants wore the PERF and DAE-RED systems was randomized (first or third), but the RX prosthesis was always worn second.
This study was conducted over 6 weeks. Subjects were fit with the study prostheses (PERF and DAE-RED) and then randomized to first wear either the PERF or DAE-RED prosthesis for two weeks before returning for data collection. Subjects were then fit with their RX prosthesis which they wore for the next two weeks to wash out intervention effects before returning for data collection. Subjects were then fit with the remaining study prosthesis (either the PERF or DAE-RED) which they wore for two weeks before returning for data collection. After wearing all three prostheses, the protocol was complete.
Participants in this group first wore PERF for two weeks, then RX for two weeks, and then DAE-RED for two weeks.
|
DAE-RED, Then RX, Then PERF
A within-subject crossover experiment was conducted to determine if differences in adherence (slippage), expulsion of perspiration, residual limb health, and comfort exist between three study suspension systems. The three suspension systems included: (1) a perforated elastomeric liner (PERF) liner intended to transport perspiration away from the residual limb, (2) a Dynamic Air Exchange - Rising Edge Design (DAE-RED) suspension system that expels perspiration to the prosthesis exterior using a hybrid battery and body weight actuated vacuum pumps, and (3) the participant's as-prescribed (RX) prosthesis. The order in which participants wore the PERF and DAE-RED systems was randomized (first or third), but the RX prosthesis was always worn second.
This study was conducted over 6 weeks. Subjects were fit with the study prostheses (PERF and DAE-RED) and then randomized to first wear either the PERF or DAE-RED prosthesis for two weeks before returning for data collection. Subjects were then fit with their RX prosthesis which they wore for the next two weeks to wash out intervention effects before returning for data collection. Subjects were then fit with the remaining study prosthesis (either the PERF or DAE-RED) which they wore for two weeks before returning for data collection. After wearing all three prostheses, the protocol was complete.
Participants in this group first wore DAE-RED for two weeks, then RX for two weeks, and then PERF for two weeks.
|
|---|---|---|
|
First Intervention (2 weeks)
STARTED
|
2
|
6
|
|
First Intervention (2 weeks)
COMPLETED
|
2
|
6
|
|
First Intervention (2 weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (2 weeks)
STARTED
|
2
|
6
|
|
Second Intervention (2 weeks)
COMPLETED
|
2
|
6
|
|
Second Intervention (2 weeks)
NOT COMPLETED
|
0
|
0
|
|
Third Intervention (2 weeks)
STARTED
|
2
|
6
|
|
Third Intervention (2 weeks)
COMPLETED
|
2
|
6
|
|
Third Intervention (2 weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adherence and Perspiration While Wearing Lower Limb Prostheses
Baseline characteristics by cohort
| Measure |
Individuals With Unilateral Transtibial Amputation
n=8 Participants
A within-subject crossover experiment was conducted to determine if differences in adherence (slippage), expulsion of perspiration, residual limb health, and comfort exist between three study suspension systems. The three suspension systems included: (1) a perforated elastomeric liner (PERF) liner intended to transport perspiration away from the residual limb, (2) a Dynamic Air Exchange - Rising Edge Design (DAE-RED) suspension system that expels perspiration to the prosthesis exterior using a hybrid battery and body weight actuated vacuum pumps, and (3) the participant's as-prescribed (RX) prosthesis. The order in which participants wore the PERF and DAE-RED systems was randomized (first or third), but the RX prosthesis was always worn second.
|
|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 15 • n=25 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Dynamic Air Exchange - Rising Edge Design (DAE-RED)
n=8 Participants
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.
|
As-Prescribed (RX)
n=8 Participants
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.
|
Perforated Liner (PERF)
n=8 Participants
The unique element of the PERF 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.
|
|---|---|---|---|
|
Adherence
|
1 millimeters
Standard Error 1
|
8 millimeters
Standard Error 4
|
3 millimeters
Standard Error 2
|
PRIMARY outcome
Timeframe: 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.Population: The As-Prescribed (RX) prosthesis cannot expel perspiration. No measurements were performed on this group.
The amount of expelled perspiration will be determined by tare weight. Expelled perspiration will be measured in grams.
Outcome measures
| Measure |
Dynamic Air Exchange - Rising Edge Design (DAE-RED)
n=8 Participants
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.
|
As-Prescribed (RX)
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.
|
Perforated Liner (PERF)
n=8 Participants
The unique element of the PERF 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.
|
|---|---|---|---|
|
Expelled Perspiration
|
0.1 grams
Standard Error 0.01
|
—
|
0.2 grams
Standard Error 0.1
|
SECONDARY outcome
Timeframe: After wearing the study prosthesis in the home, work, and community environments for two weeksSkin 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.
Outcome measures
| Measure |
Dynamic Air Exchange - Rising Edge Design (DAE-RED)
n=8 Participants
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.
|
As-Prescribed (RX)
n=8 Participants
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.
|
Perforated Liner (PERF)
n=8 Participants
The unique element of the PERF 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.
|
|---|---|---|---|
|
Skin Hydration
|
18 Units on a scale
Standard Error 4
|
21 Units on a scale
Standard Error 4
|
26 Units on a scale
Standard Error 4
|
SECONDARY outcome
Timeframe: After wearing the study prosthesis in the home, work, and community environments for two weeksTransepidermal 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.
Outcome measures
| Measure |
Dynamic Air Exchange - Rising Edge Design (DAE-RED)
n=8 Participants
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.
|
As-Prescribed (RX)
n=8 Participants
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.
|
Perforated Liner (PERF)
n=8 Participants
The unique element of the PERF 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.
|
|---|---|---|---|
|
Transepidermal Water Loss
|
12.3 grams per hour per square meter
Standard Error 2.2
|
12.8 grams per hour per square meter
Standard Error 2.2
|
9.3 grams per hour per square meter
Standard Error 2.2
|
SECONDARY outcome
Timeframe: After wearing the study prosthesis in the home, work, and community environments for two weeksAn 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.
Outcome measures
| Measure |
Dynamic Air Exchange - Rising Edge Design (DAE-RED)
n=8 Participants
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.
|
As-Prescribed (RX)
n=8 Participants
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.
|
Perforated Liner (PERF)
n=8 Participants
The unique element of the PERF 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.
|
|---|---|---|---|
|
Satisfaction With the Prosthesis
|
7 Units on a scale
Standard Error 1
|
8 Units on a scale
Standard Error 1
|
7 Units on a scale
Standard Error 1
|
Adverse Events
PERF, Then RX, Then DAE-RED
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DAE-RED, Then RX, Then PERF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Glenn K Klute, PhD
Seattle Institute for Biomedical and Clinical Research
Phone: 2062776792
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place