Heel Pressure Ulceration Prevention Strategies
Conditions
Keywords
heel, pressure ulcer, pressure mapping
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.
Interventions
OTHERPillow Condition 1
The heel is offloaded by placing the heel on a standard hospital pillow.
OTHERPillow Condition 2
The heel is offloaded by placing a standard hospital pillow under the calf suspending the heel above the hospital bed mattress.
DEVICEHeel Foam Pillow
An economy heel offloading device constructed of egg shell foam.
DEVICEOffloading 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.
DEVICEOffloading 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
DEVICEOffloading 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.
Sponsors
Lincoln Memorial University
DeRoyal Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Healthy Research Subjects | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 20 Participants | — |
| Age, Continuous | 36.5 years STANDARD_DEVIATION 14.1 | — |
| BMI, Categorical 18.5 < BMI < 24.9 | 8 Participants | — |
| BMI, Categorical 25 < BMI < 29.9 | 7 Participants | — |
| BMI, Categorical 30 < BMI | 6 Participants | — |
| Body Mass Index (BMI), Continuous | 27.3 kg/m^2 STANDARD_DEVIATION 5.7 | — |
| Height, Continuous | 65.7 inches STANDARD_DEVIATION 4.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
| Weight, Continuous | 168.6 lbs STANDARD_DEVIATION 43.5 | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 21 | 0 / 21 | 0 / 21 | 0 / 21 | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 | 0 / 21 | 0 / 21 | 0 / 21 | 0 / 21 | 0 / 21 |
Outcome results
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
Time frame: 5 minutes of pressure mapping
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Average Contact Force Exerted on the Heel | 60.25 mmHg | Standard Deviation 13.68 |
| Pillow Condition 1 | Average Contact Force Exerted on the Heel | 39.74 mmHg | Standard Deviation 10.84 |
| Pillow Condition 2 | Average Contact Force Exerted on the Heel | 5.57 mmHg | Standard Deviation 3.94 |
| Heel Foam Pillow | Average Contact Force Exerted on the Heel | 29.34 mmHg | Standard Deviation 7.67 |
| Offloading Device A | Average Contact Force Exerted on the Heel | 24.50 mmHg | Standard Deviation 9.63 |
| Offloading Device B | Average Contact Force Exerted on the Heel | 20.72 mmHg | Standard Deviation 10.25 |
| Offloading Device C | Average Contact Force Exerted on the Heel | 7.00 mmHg | Standard Deviation 12.51 |
p-value: <0.00005t-test, 2 sided
p-value: 0.24t-test, 2 sided
p-value: 0.14t-test, 2 sided
p-value: 0.0093t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: 0.14t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005Repeated Measures ANOVA
p-value: 0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: 0.01t-test, 2 sided
p-value: 0.0002t-test, 2 sided
p-value: <0.00005t-test, 2 sided
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.
Time frame: 5 minutes of pressure mapping
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Peak Pressure Index on the Heel | 120.15 mmHg | Standard Deviation 23.88 |
| Pillow Condition 1 | Peak Pressure Index on the Heel | 69.93 mmHg | Standard Deviation 17.63 |
| Pillow Condition 2 | Peak Pressure Index on the Heel | 10.97 mmHg | Standard Deviation 8.42 |
| Heel Foam Pillow | Peak Pressure Index on the Heel | 48.06 mmHg | Standard Deviation 9.87 |
| Offloading Device A | Peak Pressure Index on the Heel | 39.88 mmHg | Standard Deviation 18.01 |
| Offloading Device B | Peak Pressure Index on the Heel | 32.18 mmHg | Standard Deviation 14.71 |
| Offloading Device C | Peak Pressure Index on the Heel | 12.51 mmHg | Standard Deviation 8.26 |
p-value: <0.00005Repeated Measures ANOVA
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: 0.0011t-test, 2 sided
p-value: 0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: 0.53t-test, 2 sided
p-value: 0.092t-test, 2 sided
p-value: 0.0044t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: 0.084t-test, 2 sided
p-value: <0.00005t-test, 2 sided
p-value: 0.00005t-test, 2 sided