Evaluation of Heel Offloading Devices for Reducing Heel Contact Pressures in Healthy Volunteers
Sponsor
DeRoyal Industries, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02811965
Collaborator
Lincoln Memorial University (Other)
21
1
7
5
4.2
Study Details
Study Description
Brief Summary
Prevention of heel pressure ulceration is a major clinical concern. Clinical research has shown that heel-offloading devices are effective at preventing heel ulceration when compared to no offloading or sub-optimal offloading methods (i.e. use of a hospital pillow to offload the heel). As a result, a plethora of heel-offloading devices have been developed that utilize different designs and materials to offload the heel. Despite the availability of these devices, some healthcare facilities still employ no heel offloading or utilize sub-optimal heel offloading strategies. It is also difficult for clinicians to compare the effectiveness of different heel offloading device without conducting extensive clinical evaluations. Pressure mapping of the pressure experienced by the heel while offloaded offers a potential method to assess the effectiveness of different heel offloading strategies.
The primary hypothesis of this study is that the three tested heel offloading devices will significantly decrease the heel contact forces compared to no offloading and sub-optimal heel offloading conditions. The secondary objective is to quantify differences in heel contact forces experienced by the heel when placed in each heel offloading device to demonstrate the utility of pressure mapping as a tool to evaluate the effectiveness of different heel offloading devices.
The study will recruit 21 healthy volunteers as research subjects with 7 having a normal BMI, 7 having an overweight BMI, and 7 having an obese BMI. Pressure mapping will be conducted on each research subject for seven randomly applied conditions while the patient lies comfortably in a hospital bed. The seven conditions include no heel offloading, 3 sub-optimal offloading conditions, and offloading in 3 different heel-offloading devices. Pressure measurements corresponding to the heel will be used to determine the average peak pressure contact force for each research subject in each condition.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
21 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Each research subject will have pressure mapping performed on his or her right foot in the 7 conditions described for each study arm to determine the contact forces experienced by the heel in each off-loading condition. Each intervention will be randomly applied.Each research subject will have pressure mapping performed on his or her right foot in the 7 conditions described for each study arm to determine the contact forces experienced by the heel in each off-loading condition. Each intervention will be randomly applied.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Evaluation of Heel Offloading Devices for Reducing Heel Contact Pressures in Healthy Volunteers
Study Start Date
:
Jun 1, 2016
Actual Primary Completion Date
:
Nov 1, 2016
Actual Study Completion Date
:
Nov 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control Pressure mapping is performed without a heel offloading intervention applied. |
|
| Experimental: Pillow Condition 1 Pressure mapping is performed with the Pillow condition 1 intervention applied to the heel. |
Other: Pillow Condition 1
The heel is offloaded by placing the heel on a standard hospital pillow.
|
| Experimental: Pillow Condition 2 Pressure mapping is performed with the Pillow condition 2 applied to the heel. |
Other: Pillow Condition 2
The heel is offloaded by placing a standard hospital pillow under the calf suspending the heel above the hospital bed mattress.
|
| Experimental: Heel Foam Pillow Pressure mapping is performed with the heel foam pillow device applied to the heel. |
Device: Heel Foam Pillow
An economy heel offloading device constructed of egg shell foam.
|
| Experimental: Offloading Device A Pressure mapping is performed with Offloading Device A applied to the heel. |
Device: Offloading Device A
Heel offloading device that utilizes open cell foam to offload the heel. Device has a published clinical study demonstrating effectiveness at reducing heel ulceration rate.
|
| Experimental: Offloading Device B Pressure mapping is performed with Offloading Device B applied to the heel. |
Device: Offloading Device B
Heel offloading device that utilizes pressure absorbing filling to offload the heel. Device has a published clinical study demonstrating effectiveness at reducing heel ulceration rate
|
| Experimental: Offloading Device C Pressure mapping is performed with Offloading Device C applied to the heel. |
Device: Offloading Device C
Heel offloading device that utilizes a similar pressure absorbing filling to Offloading Device B; however this device does not have published clinical literature demonstrating effectiveness at reducing heel ulceration in the clinic.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Average Contact Force Exerted on the Heel [5 minutes of pressure mapping]
Average contact force calculated from an area of 40.32 cm^2 that encompassed the entire posterior heel. Pressure readings obtained by pressure mapping
- Peak Pressure Index on the Heel [5 minutes of pressure mapping]
Peak 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
18 years old or older
-
No musculoskeletal injury in the past month
-
Body Mass Index (BMI) between 18.5 and 39.9
Exclusion Criteria:
-
17 years old or younger
-
Musculoskeletal injury in the past month
-
Pregnant or lactating female
-
History of heel pressure ulceration
-
BMI below 18.5 or above 39.9
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lincoln Memorial University; Cedar Bluff Campus | Knoxville | Tennessee | United States | 37923 |
Sponsors and Collaborators
- DeRoyal Industries, Inc.
- Lincoln Memorial University
Investigators
- Principal Investigator: Jennifer Savage, DNP, Lincoln Memorial University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
DeRoyal Industries, Inc.
ClinicalTrials.gov Identifier:
NCT02811965
Other Study ID Numbers:
- 534
First Posted:
Jun 23, 2016
Last Update Posted:
Jan 8, 2018
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by DeRoyal Industries, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Healthy Research Subjects |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 21 |
| COMPLETED | 21 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Healthy Research Subjects |
|---|---|
| Arm/Group Description | 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 Participants | 21 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
20
95.2%
|
| >=65 years |
1
4.8%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
36.5
(14.1)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
17
81%
|
| Male |
4
19%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Weight, Continuous (lbs) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [lbs] |
168.6
(43.5)
|
| Height, Continuous (inches) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [inches] |
65.7
(4.2)
|
| Body Mass Index (BMI), Continuous (kg/m^2) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [kg/m^2] |
27.3
(5.7)
|
| BMI, Categorical (Count of Participants) | |
| 18.5 < BMI < 24.9 |
8
38.1%
|
| 25 < BMI < 29.9 |
7
33.3%
|
| 30 < BMI |
6
28.6%
|
Outcome Measures
| Title | Average Contact Force Exerted on the Heel |
|---|---|
| Description | Average contact force calculated from an area of 40.32 cm^2 that encompassed the entire posterior heel. Pressure readings obtained by pressure mapping |
| Time Frame | 5 minutes of pressure mapping |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Pillow Condition 1 | Pillow Condition 2 | Heel Foam Pillow | Offloading Device A | Offloading Device B | Offloading Device C |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Pressure mapping is performed without a heel offloading intervention applied. | Pressure mapping is performed with the Pillow condition 1 intervention applied to the heel. | Pressure mapping is performed with the Pillow condition 2 applied to the heel. | Pressure mapping is performed with the heel foam pillow device applied to the heel. | Pressure mapping is performed with Offloading Device A applied to the heel. | Pressure mapping is performed with Offloading Device B applied to the heel. | Pressure mapping is performed with Offloading Device C applied to the heel. |
| Measure Participants | 21 | 21 | 21 | 21 | 21 | 21 | 21 |
| Mean (Standard Deviation) [mmHg] |
60.25
(13.68)
|
39.74
(10.84)
|
5.57
(3.94)
|
29.34
(7.67)
|
24.50
(9.63)
|
20.72
(10.25)
|
7.00
(12.51)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Control, Pillow Condition 1, Pillow Condition 2, Heel Foam Pillow, Offloading Device A, Offloading Device B, Offloading Device C |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | A priori threshold p < 0.05 | |
| Method | Repeated Measures ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Control, Pillow Condition 1 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Control, Pillow Condition 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Control, Heel Foam Pillow |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Control, Offloading Device A |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Control, Offloading Device B |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Control, Offloading Device C |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 1, Pillow Condition 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 1, Heel Foam Pillow |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.01 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 1, Offloading Device A |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0002 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 1, Offloading Device B |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 1, Offloading Device C |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 2, Heel Foam Pillow |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 2, Offloading Device A |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 2, Offloading Device B |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 2, Offloading Device C |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.24 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Heel Foam Pillow, Offloading Device A |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.14 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Heel Foam Pillow, Offloading Device B |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0093 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Heel Foam Pillow, Offloading Device C |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Offloading Device A, Offloading Device B |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.14 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Offloading Device A, Offloading Device C |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Offloading Device B, Offloading Device C |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Peak Pressure Index on the Heel |
|---|---|
| Description | Peak 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. |
| Time Frame | 5 minutes of pressure mapping |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Pillow Condition 1 | Pillow Condition 2 | Heel Foam Pillow | Offloading Device A | Offloading Device B | Offloading Device C |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Pressure mapping is performed without a heel offloading intervention applied. | Pressure mapping is performed with the Pillow condition 1 intervention applied to the heel. | Pressure mapping is performed with the Pillow condition 2 applied to the heel. | Pressure mapping is performed with the heel foam pillow device applied to the heel. | Pressure mapping is performed with Offloading Device A applied to the heel. | Pressure mapping is performed with Offloading Device B applied to the heel. | Pressure mapping is performed with Offloading Device C applied to the heel. |
| Measure Participants | 21 | 21 | 21 | 21 | 21 | 21 | 21 |
| Mean (Standard Deviation) [mmHg] |
120.15
(23.88)
|
69.93
(17.63)
|
10.97
(8.42)
|
48.06
(9.87)
|
39.88
(18.01)
|
32.18
(14.71)
|
12.51
(8.26)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Control, Pillow Condition 1, Pillow Condition 2, Heel Foam Pillow, Offloading Device A, Offloading Device B, Offloading Device C |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | A priori threshold p<0.05. | |
| Method | Repeated Measures ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Control, Pillow Condition 1 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Control, Pillow Condition 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Control, Heel Foam Pillow |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Control, Offloading Device A |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Control, Offloading Device B |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Control, Offloading Device C |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 1, Pillow Condition 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 1, Heel Foam Pillow |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0011 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 1, Offloading Device A |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 1, Offloading Device B |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 1, Offloading Device C |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 2, Heel Foam Pillow |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 2, Offloading Device A |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 2, Offloading Device B |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pillow Condition 2, Offloading Device C |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.53 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Heel Foam Pillow, Offloading Device A |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.092 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Heel Foam Pillow, Offloading Device B |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0044 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Heel Foam Pillow, Offloading Device C |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Offloading Device A, Offloading Device B |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.084 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Offloading Device A, Offloading Device C |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Offloading Device B, Offloading Device C |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00005 |
| Comments | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | |
| Method | t-test, 2 sided | |
| Comments | ||
Adverse Events
| Time Frame | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||
| Arm/Group Title | Control | Pillow Condition 1 | Pillow Condition 2 | Heel Foam Pillow | Offloading Device A | Offloading Device B | Offloading Device C | |||||||
| Arm/Group Description | Pressure mapping is performed without a heel offloading intervention applied. | Pressure mapping is performed with the Pillow condition 1 intervention applied to the heel. | Pressure mapping is performed with the Pillow condition 2 applied to the heel. | Pressure mapping is performed with the heel foam pillow device applied to the heel. | Pressure mapping is performed with Offloading Device A applied to the heel. | Pressure mapping is performed with Offloading Device B applied to the heel. | Pressure mapping is performed with Offloading Device C applied to the heel. | |||||||
All Cause Mortality |
||||||||||||||
| Control | Pillow Condition 1 | Pillow Condition 2 | Heel Foam Pillow | Offloading Device A | Offloading Device B | Offloading Device C | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||
Serious Adverse Events |
||||||||||||||
| Control | Pillow Condition 1 | Pillow Condition 2 | Heel Foam Pillow | Offloading Device A | Offloading Device B | Offloading Device C | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
| Control | Pillow Condition 1 | Pillow Condition 2 | Heel Foam Pillow | Offloading Device A | Offloading Device B | Offloading Device C | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) | |||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Jennifer Savage, DNP, APN, FNP-BC |
|---|---|
| Organization | Lincoln Memorial University |
| Phone | |
| jennifer.savage@lmunet.edu |
Responsible Party:
DeRoyal Industries, Inc.
ClinicalTrials.gov Identifier:
NCT02811965
Other Study ID Numbers:
- 534
First Posted:
Jun 23, 2016
Last Update Posted:
Jan 8, 2018
Last Verified:
Jan 1, 2018