Heel Pressure Ulceration Prevention StrategiesNCT02811965
Evaluation of Heel Offloading Devices for Reducing Heel Contact Pressures in Healthy Volunteers
A study testing Pillow Condition 1, Pillow Condition 2 and Heel Foam Pillow in people with Heel Pressure Ulceration Prevention Strategies, run by DeRoyal Industries, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heel Pressure Ulceration Prevention Strategies
- What is being tested?
- Pillow Condition 1, Pillow Condition 2 and Heel Foam Pillow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or older
- No musculoskeletal injury in the past month
- Body Mass Index (BMI) between 18.5 and 39.9
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lincoln Memorial University; Cedar Bluff Campus
Knoxville, Tennessee, 37923
About this study
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.
- Being tested
- Pillow Condition 1, Pillow Condition 2, Heel Foam Pillow, Offloading Device A, Offloading Device B
- Keywords
- heel, pressure ulcer, pressure mapping
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pillow Condition 1Other
The heel is offloaded by placing the heel on a standard hospital pillow.
Pillow Condition 2Other
The heel is offloaded by placing a standard hospital pillow under the calf suspending the heel above the hospital bed mattress.
Heel Foam PillowDevice
An economy heel offloading device constructed of egg shell foam.
Offloading Device ADevice
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.
Offloading Device BDevice
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
Offloading Device CDevice
Also called PRUventor® Heel Off-loading 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pillow Condition 1 |
| Pillow Condition 2 | Experimental | Pressure mapping is performed with the Pillow condition 2 applied to the heel. Receives: Other: Pillow Condition 2 |
| Heel Foam Pillow | Experimental | Pressure mapping is performed with the heel foam pillow device applied to the heel. Receives: Device: Heel Foam Pillow |
| Offloading Device A | Experimental | Pressure mapping is performed with Offloading Device A applied to the heel. Receives: Device: Offloading Device A |
| Offloading Device B | Experimental | Pressure mapping is performed with Offloading Device B applied to the heel. Receives: Device: Offloading Device B |
| Offloading Device C | Experimental | Pressure mapping is performed with Offloading Device C applied to the heel. Receives: Device: Offloading Device C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 5 minutes of pressure mapping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heel Pressure Ulceration Prevention StrategiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeRoyal Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lincoln Memorial University
- Responsible party
- Sponsor
- Investigators
- Jennifer Savage, DNP, Principal investigator, Lincoln Memorial University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811965
- Sponsor's protocol ID
- 534
- Status last verified
- Jan 2018
- First submitted
- 21 Jun 2016
- Last updated
- 8 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Heel Offloading Devices for Reducing Heel Contact Pressures in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02811965
- Acronym / sponsor ID
- 534
- Keywords
- heel, pressure ulcer, pressure mapping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- DeRoyal Industries, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Lincoln Memorial University
- Study start
- Jun 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Posted 7 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 7
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Pressure mapping is performed without a heel offloading intervention applied. |
| Pillow Condition 1 | Experimental | Other: Pillow Condition 1Pressure mapping is performed with the Pillow condition 1 intervention applied to the heel. |
| Pillow Condition 2 | Experimental | Other: Pillow Condition 2Pressure mapping is performed with the Pillow condition 2 applied to the heel. |
| Heel Foam Pillow | Experimental | Device: Heel Foam PillowPressure mapping is performed with the heel foam pillow device applied to the heel. |
| Offloading Device A | Experimental | Device: Offloading Device APressure mapping is performed with Offloading Device A applied to the heel. |
| Offloading Device B | Experimental | Device: Offloading Device BPressure mapping is performed with Offloading Device B applied to the heel. |
| Offloading Device C | Experimental | Device: Offloading Device CPressure mapping is performed with Offloading Device C applied to the heel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old or older
- No musculoskeletal injury in the past month
- Body Mass Index (BMI) between 18.5 and 39.9
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pillow Condition 1The heel is offloaded by placing the heel on a standard hospital pillow. | Other | Pillow Condition 1 |
| Pillow Condition 2The heel is offloaded by placing a standard hospital pillow under the calf suspending the heel above the hospital bed mattress. | Other | Pillow Condition 2 |
| Heel Foam PillowAn economy heel offloading device constructed of egg shell foam. | Device | Heel Foam Pillow |
| Offloading Device AHeel offloading device that utilizes open cell foam to offload the heel. Device has a published clinical study demonstrating effectiveness at reducing heel ulceration rate. | Device | Offloading Device A |
| Offloading Device BHeel offloading device that utilizes pressure absorbing filling to offload the heel. Device has a published clinical study demonstrating effectiveness at reducing heel ulceration rate | Device | Offloading Device B |
| Offloading Device CAlso: PRUventor® Heel Off-loading DeviceHeel 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. | Device | Offloading Device C |
Primary outcome
Average Contact Force Exerted on the Heel
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Savage, DNP principal investigator
Lincoln Memorial University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pillow Condition 1, Pillow Condition 2 and Heel Foam Pillow in people with Heel Pressure Ulceration Prevention Strategies, run by DeRoyal Industries, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Contact Force Exerted on the Heel (time frame: 5 minutes of pressure mapping). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018.