Trial Outcomes & Findings for Evaluation of Heel Offloading Devices for Reducing Heel Contact Pressures in Healthy Volunteers (NCT NCT02811965)
NCT ID: NCT02811965
Last Updated: 2018-01-08
Results Overview
Average contact force calculated from an area of 40.32 cm\^2 that encompassed the entire posterior heel. Pressure readings obtained by pressure mapping
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
5 minutes of pressure mapping
Results posted on
2018-01-08
Participant Flow
Participant milestones
| Measure |
Healthy Research Subjects
Each research subject will have pressure mapping performed on his or her right foot in the 7 interventions listed to determine the contact forces experienced by the heel in each off-loading condition. Each intervention will be randomly applied.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healthy Research Subjects
n=21 Participants
Each research subject will have pressure mapping performed on his or her right foot in the 7 interventions listed to determine the contact forces experienced by the heel in each off-loading condition. Each intervention will be randomly applied.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=21 Participants
|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 14.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=21 Participants
|
|
Weight, Continuous
|
168.6 lbs
STANDARD_DEVIATION 43.5 • n=21 Participants
|
|
Height, Continuous
|
65.7 inches
STANDARD_DEVIATION 4.2 • n=21 Participants
|
|
Body Mass Index (BMI), Continuous
|
27.3 kg/m^2
STANDARD_DEVIATION 5.7 • n=21 Participants
|
|
BMI, Categorical
18.5 < BMI < 24.9
|
8 Participants
n=21 Participants
|
|
BMI, Categorical
25 < BMI < 29.9
|
7 Participants
n=21 Participants
|
|
BMI, Categorical
30 < BMI
|
6 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 5 minutes of pressure mappingAverage contact force calculated from an area of 40.32 cm\^2 that encompassed the entire posterior heel. Pressure readings obtained by pressure mapping
Outcome measures
| Measure |
Control
n=21 Participants
Pressure mapping is performed without a heel offloading intervention applied.
|
Pillow Condition 1
n=21 Participants
Pressure mapping is performed with the Pillow condition 1 intervention applied to the heel.
|
Pillow Condition 2
n=21 Participants
Pressure mapping is performed with the Pillow condition 2 applied to the heel.
|
Heel Foam Pillow
n=21 Participants
Pressure mapping is performed with the heel foam pillow device applied to the heel.
|
Offloading Device A
n=21 Participants
Pressure mapping is performed with Offloading Device A applied to the heel.
|
Offloading Device B
n=21 Participants
Pressure mapping is performed with Offloading Device B applied to the heel.
|
Offloading Device C
n=21 Participants
Pressure mapping is performed with Offloading Device C applied to the heel.
|
|---|---|---|---|---|---|---|---|
|
Average Contact Force Exerted on the Heel
|
60.25 mmHg
Standard Deviation 13.68
|
39.74 mmHg
Standard Deviation 10.84
|
5.57 mmHg
Standard Deviation 3.94
|
29.34 mmHg
Standard Deviation 7.67
|
24.50 mmHg
Standard Deviation 9.63
|
20.72 mmHg
Standard Deviation 10.25
|
7.00 mmHg
Standard Deviation 12.51
|
PRIMARY outcome
Timeframe: 5 minutes of pressure mappingPeak pressure index calculated by centering a 3 X 3 region of interest (14.52 cm\^2) over maximum pressure sensor reading within the region of interest encompassing the heel.
Outcome measures
| Measure |
Control
n=21 Participants
Pressure mapping is performed without a heel offloading intervention applied.
|
Pillow Condition 1
n=21 Participants
Pressure mapping is performed with the Pillow condition 1 intervention applied to the heel.
|
Pillow Condition 2
n=21 Participants
Pressure mapping is performed with the Pillow condition 2 applied to the heel.
|
Heel Foam Pillow
n=21 Participants
Pressure mapping is performed with the heel foam pillow device applied to the heel.
|
Offloading Device A
n=21 Participants
Pressure mapping is performed with Offloading Device A applied to the heel.
|
Offloading Device B
n=21 Participants
Pressure mapping is performed with Offloading Device B applied to the heel.
|
Offloading Device C
n=21 Participants
Pressure mapping is performed with Offloading Device C applied to the heel.
|
|---|---|---|---|---|---|---|---|
|
Peak Pressure Index on the Heel
|
120.15 mmHg
Standard Deviation 23.88
|
69.93 mmHg
Standard Deviation 17.63
|
10.97 mmHg
Standard Deviation 8.42
|
48.06 mmHg
Standard Deviation 9.87
|
39.88 mmHg
Standard Deviation 18.01
|
32.18 mmHg
Standard Deviation 14.71
|
12.51 mmHg
Standard Deviation 8.26
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pillow Condition 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pillow Condition 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Heel Foam Pillow
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Offloading Device A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Offloading Device B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Offloading Device C
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
Restriction type: LTE60