Trial Outcomes & Findings for Moisture Management Liner Effectiveness Study (NCT NCT04427007)
NCT ID: NCT04427007
Last Updated: 2025-05-11
Results Overview
Changes in residual limb temperature during walking/resting measured with temperature sensors placed on the limb. Positive values signify a raise in temperature and negative values signify a drop in temperature between the start of walking to the end of walking.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
2 hours
Results posted on
2025-05-11
Participant Flow
Participant milestones
| Measure |
Experimental Liner, Then Control Liner
Participants will test the experimental prosthetic liner by walking on a treadmill while wearing the liner. They will then test the control liner by walking on the treadmill while wearing their usual prosthetic liner.
Moisture Management Liner: A prototype prosthetic liner designed to reduce and/or remove moisture and heat that builds up on the limb.
|
Control Liner, Then Experimental Liner
Participants will test the control (participant's usual) liner by walking on a treadmill while wearing the liner. They will then test the experimental prosthetic liner by walking on a treadmill while wearing the liner.
Control Liner: The participant's usual prosthetic liner
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Experimental Liner, Then Control Liner
Participants will test the experimental prosthetic liner by walking on a treadmill while wearing the liner. They will then test the control liner by walking on the treadmill while wearing their usual prosthetic liner.
Moisture Management Liner: A prototype prosthetic liner designed to reduce and/or remove moisture and heat that builds up on the limb.
|
Control Liner, Then Experimental Liner
Participants will test the control (participant's usual) liner by walking on a treadmill while wearing the liner. They will then test the experimental prosthetic liner by walking on a treadmill while wearing the liner.
Control Liner: The participant's usual prosthetic liner
|
|---|---|---|
|
Overall Study
Unable to use the experimental liner due to suspension issues. Incomplete data collection.
|
0
|
1
|
Baseline Characteristics
Moisture Management Liner Effectiveness Study
Baseline characteristics by cohort
| Measure |
Experimental Liner, Then Control Liner
n=1 Participants
Participants will test the experimental prosthetic liner by walking on a treadmill while wearing the liner. They will then test the control liner by walking on the treadmill while wearing their usual prosthetic liner.
Moisture Management Liner: A prototype prosthetic liner designed to reduce and/or remove moisture and heat that builds up on the limb.
|
Control Liner, Then Experimental Liner
n=1 Participants
Participants will test the control (participant's usual) liner by walking on a treadmill while wearing the liner. They will then test the experimental prosthetic liner by walking on a treadmill while wearing the liner.
Control Liner: The participant's usual prosthetic liner
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: Data only reported for the subject who completed both conditions.
Changes in residual limb temperature during walking/resting measured with temperature sensors placed on the limb. Positive values signify a raise in temperature and negative values signify a drop in temperature between the start of walking to the end of walking.
Outcome measures
| Measure |
Experimental Prosthetic Liner
n=1 Participants
Participants will test the experimental prosthetic liner by walking on a treadmill while wearing the liner.
Moisture Management Liner: A prototype prosthetic liner designed to reduce and/or remove moisture and heat that builds up on the limb.
|
Control Prosthetic Liner
n=1 Participants
Participants will test the control (participant's usual) liner by walking on a treadmill while wearing the liner.
Control Liner: The participant's usual prosthetic liner
|
|---|---|---|
|
Residual Limb Temperature
|
3.0 Degrees Fahrenheit
|
3.2 Degrees Fahrenheit
|
Adverse Events
Experimental Prosthetic Liner
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Prosthetic Liner
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place