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| Name | Class |
|---|---|
| Lincoln Memorial University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Pressure mapping is performed without a heel offloading intervention applied. | |
| Pillow Condition 1 | Experimental | Pressure mapping is performed with the Pillow condition 1 intervention applied to the heel. |
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| Pillow Condition 2 | Experimental | Pressure mapping is performed with the Pillow condition 2 applied to the heel. |
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| Heel Foam Pillow | Experimental | Pressure mapping is performed with the heel foam pillow device applied to the heel. |
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| Offloading Device A | Experimental | Pressure mapping is performed with Offloading Device A applied to the heel. |
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| Offloading Device B | Experimental | Pressure mapping is performed with Offloading Device B applied to the heel. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pillow Condition 1 | Other | The heel is offloaded by placing the heel on a standard hospital pillow. |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Contact Force Exerted on the Heel | Average contact force calculated from an area of 40.32 cm^2 that encompassed the entire posterior heel. Pressure readings obtained by pressure mapping | 5 minutes of pressure mapping |
| Peak Pressure Index on the Heel | 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. | 5 minutes of pressure mapping |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Savage, DNP | Lincoln Memorial University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lincoln Memorial University; Cedar Bluff Campus | Knoxville | Tennessee | 37923 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| Offloading Device C | Experimental | Pressure mapping is performed with Offloading Device C applied to the heel. |
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| Pillow Condition 2 | Other | The heel is offloaded by placing a standard hospital pillow under the calf suspending the heel above the hospital bed mattress. |
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| Heel Foam Pillow | Device | An economy heel offloading device constructed of egg shell foam. |
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| Offloading Device A | Device | 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. |
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| Offloading Device B | Device | 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 |
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| Offloading Device C | Device | 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Weight, Continuous | Mean | Standard Deviation | lbs |
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| Height, Continuous | Mean | Standard Deviation | inches |
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| Body Mass Index (BMI), Continuous | Mean | Standard Deviation | kg/m^2 |
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| BMI, Categorical | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Average Contact Force Exerted on the Heel | Average contact force calculated from an area of 40.32 cm^2 that encompassed the entire posterior heel. Pressure readings obtained by pressure mapping | Posted | Mean | Standard Deviation | mmHg | 5 minutes of pressure mapping |
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| Primary | Peak Pressure Index on the Heel | 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. | Posted | Mean | Standard Deviation | mmHg | 5 minutes of pressure mapping |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Pressure mapping is performed without a heel offloading intervention applied. | 0 | 21 | 0 | 21 | ||
| EG001 | Pillow Condition 1 | Pressure mapping is performed with the Pillow condition 1 intervention applied to the heel. | 0 | 21 | 0 | 21 | ||
| EG002 | Pillow Condition 2 | Pressure mapping is performed with the Pillow condition 2 applied to the heel. | 0 | 21 | 0 | 21 | ||
| EG003 | Heel Foam Pillow | Pressure mapping is performed with the heel foam pillow device applied to the heel. | 0 | 21 | 0 | 21 | ||
| EG004 | Offloading Device A | Pressure mapping is performed with Offloading Device A applied to the heel. | 0 | 21 | 0 | 21 | ||
| EG005 | Offloading Device B | Pressure mapping is performed with Offloading Device B applied to the heel. | 0 | 21 | 0 | 21 | ||
| EG006 | Offloading Device C | Pressure mapping is performed with Offloading Device C applied to the heel. | 0 | 21 | 0 | 21 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Savage, DNP, APN, FNP-BC | Lincoln Memorial University | jennifer.savage@lmunet.edu |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| >=65 years |
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| 30 < BMI |
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| 0.00005 |
P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. |
| Superiority |
| t-test, 2 sided | <0.00005 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | <0.00005 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | <0.00005 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | <0.00005 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | <0.00005 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | <0.00005 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | 0.01 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | 0.0002 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | <0.00005 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | <0.00005 | Superiority |
| t-test, 2 sided | <0.00005 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | <0.00005 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | <0.00005 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | 0.24 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | 0.14 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | 0.0093 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | <0.00005 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | 0.14 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | <0.00005 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
| t-test, 2 sided | <0.00005 | P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05. | Superiority |
Pressure mapping is performed with Offloading Device A applied to the heel.
| OG005 | Offloading Device B | Pressure mapping is performed with Offloading Device B applied to the heel. |
| OG006 | Offloading Device C | Pressure mapping is performed with Offloading Device C applied to the heel. |
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