Trial Outcomes & Findings for Socket Cooling Effectiveness Take Home Study (NCT NCT04484805)
NCT ID: NCT04484805
Last Updated: 2024-10-22
Results Overview
This will be tested only during in-lab visits. An intervention of the experimental socket with the ICE cooling unit should yield at least a 2 degree Celsius decrease in temperature compared with no intervention. This will be tested in-lab with 6 thermocouples taped to the residual limb while the subject is sitting and walking on a treadmill. The reported result is the temperature difference of the residual limb from the baseline temperature (before activity) to the end of the sitting period (after activity). The ICE or Sham unit is turned on 5 minutes before the 15 minute walking period. After the 15 minute walking period, the participant sits with the unit ON for 45 minutes. The baseline temperature reading is taken directly before the unit is turned on, and the end temperature reading is taken after the 45 minutes of sitting.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
4 hours
Results posted on
2024-10-22
Participant Flow
Participant milestones
| Measure |
ICE Unit First, Then Sham Unit
The subject wears the experimental socket with an ICE Unit, which includes a TEC and will be actively cooling the leg whenever the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month.
The subject is then swapped to the Sham condition, which is the same setup as above except it excludes a TEC and will not be actively cooling the leg when the device is powered on. They will be in this condition for approximately one month.
ICE Condition: Experimental socket integrated with a heat spreader. An ICE Unit (includes TEC) is attached to the socket.
Sham Condition: Experimental socket integrated with a heat spreader. A Sham Unit (excludes TEC) is attached to the socket.
|
Sham Unit First, Then ICE Unit
The subject wears the experimental socket with a Sham Unit, which excludes a TEC and will not be actively cooling the leg when the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month.
The subject is then swapped to the ICE condition, which is the same setup as above except it includes a TEC and will be actively cooling the leg when the device is powered on. They will be in this condition for approximately one month.
ICE Condition: Experimental socket integrated with a heat spreader. An ICE Unit (includes TEC) is attached to the socket.
Sham Condition: Experimental socket integrated with a heat spreader. A Sham Unit (excludes TEC) is attached to the socket.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
ICE Unit First, Then Sham Unit
The subject wears the experimental socket with an ICE Unit, which includes a TEC and will be actively cooling the leg whenever the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month.
The subject is then swapped to the Sham condition, which is the same setup as above except it excludes a TEC and will not be actively cooling the leg when the device is powered on. They will be in this condition for approximately one month.
ICE Condition: Experimental socket integrated with a heat spreader. An ICE Unit (includes TEC) is attached to the socket.
Sham Condition: Experimental socket integrated with a heat spreader. A Sham Unit (excludes TEC) is attached to the socket.
|
Sham Unit First, Then ICE Unit
The subject wears the experimental socket with a Sham Unit, which excludes a TEC and will not be actively cooling the leg when the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month.
The subject is then swapped to the ICE condition, which is the same setup as above except it includes a TEC and will be actively cooling the leg when the device is powered on. They will be in this condition for approximately one month.
ICE Condition: Experimental socket integrated with a heat spreader. An ICE Unit (includes TEC) is attached to the socket.
Sham Condition: Experimental socket integrated with a heat spreader. A Sham Unit (excludes TEC) is attached to the socket.
|
|---|---|---|
|
Overall Study
LTI_H01 piloted the device and was too familiar with the study design to be unblinded/analyzed
|
1
|
0
|
|
Overall Study
LTI_H02 had socket fit issues causing discomfort which caused us to withdraw them from the study.
|
1
|
0
|
Baseline Characteristics
Socket Cooling Effectiveness Take Home Study
Baseline characteristics by cohort
| Measure |
ICE Unit, Then Sham Unit
n=6 Participants
The subject wears the experimental socket with an ICE Unit, which includes a TEC and will be actively cooling the leg whenever the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month.
The subject is then swapped to the Sham condition, which is the same setup as above except it excludes a TEC and will not be actively cooling the leg when the device is powered on. They will be in this condition for approximately one month.
ICE Condition: Experimental socket integrated with a heat spreader. An ICE Unit (includes TEC) is attached to the socket.
Sham Condition: Experimental socket integrated with a heat spreader. A Sham Unit (excludes TEC) is attached to the socket.
|
Sham Unit, Then ICE Unit
n=6 Participants
The subject wears the experimental socket with a Sham Unit, which excludes a TEC and will not be actively cooling the leg when the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month.
The subject is then swapped to the ICE condition, which is the same setup as above except it includes a TEC and will be actively cooling the leg when the device is powered on. They will be in this condition for approximately one month.
ICE Condition: Experimental socket integrated with a heat spreader. An ICE Unit (includes TEC) is attached to the socket.
Sham Condition: Experimental socket integrated with a heat spreader. A Sham Unit (excludes TEC) is attached to the socket.
|
Total
n=12 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
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 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
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 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
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hoursThis will be tested only during in-lab visits. An intervention of the experimental socket with the ICE cooling unit should yield at least a 2 degree Celsius decrease in temperature compared with no intervention. This will be tested in-lab with 6 thermocouples taped to the residual limb while the subject is sitting and walking on a treadmill. The reported result is the temperature difference of the residual limb from the baseline temperature (before activity) to the end of the sitting period (after activity). The ICE or Sham unit is turned on 5 minutes before the 15 minute walking period. After the 15 minute walking period, the participant sits with the unit ON for 45 minutes. The baseline temperature reading is taken directly before the unit is turned on, and the end temperature reading is taken after the 45 minutes of sitting.
Outcome measures
| Measure |
ICE Unit
n=12 Participants
The subject wears the experimental socket with an ICE Unit, which includes a TEC and will be actively cooling the leg whenever the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month.
ICE Condition: Experimental socket integrated with a heat spreader. An ICE Unit (includes TEC) is attached to the socket.
|
Sham Unit
n=12 Participants
The subject wears the experimental socket with a Sham Unit, which excludes a TEC and will not be actively cooling the leg when the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month.
Sham Condition: Experimental socket integrated with a heat spreader. A Sham Unit (excludes TEC) is attached to the socket.
|
|---|---|---|
|
Residual Limb Temperature
|
-2.3 Avg Temp Diff from Baseline (Degrees C)
Standard Deviation 0.9
|
1.9 Avg Temp Diff from Baseline (Degrees C)
Standard Deviation 2.0
|
Adverse Events
ICE Unit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Unit
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