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NCT02811965 · ClinicalTrials.gov registry record · NA
Evaluation of Heel Offloading Devices for Reducing Heel Contact Pressures in Healthy Volunteers
A NA study of Heel Pressure Ulceration Prevention Strategies, sponsored by DeRoyal Industries.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT02811965 is a NA study of Heel Pressure Ulceration Prevention Strategies that has completed, run by DeRoyal Industries. The registered enrollment target is 21 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02811965, a NA study of Heel Pressure Ulceration Prevention Strategies, has completed, sponsored by DeRoyal Industries.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER Pillow Condition 1
- OTHER Pillow Condition 2
- DEVICE Heel Foam Pillow
- DEVICE Offloading Device A
- DEVICE Offloading Device B
Study Locations (1)
Tennessee
- Lincoln Memorial University; Cedar Bluff Campus - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2016-06 |
| Est. Completion | 2016-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02811965
The ClinicalTrials.gov registry entry for NCT02811965 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DeRoyal Industries, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Heel Pressure Ulceration Prevention Strategies appearing as the primary indexed condition, and to 5 interventions - of which Pillow Condition 1 is the first listed.
NCT02811965 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT02811965 about?
NCT02811965 is a clinical study titled "Evaluation of Heel Offloading Devices for Reducing Heel Contact Pressures in Healthy Volunteers". 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, ...
What is the current status of trial NCT02811965?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2016-06. Estimated completion is 2016-11.
What conditions does trial NCT02811965 study?
This clinical trial studies the following conditions: Heel Pressure Ulceration Prevention Strategies.
What interventions are being tested in trial NCT02811965?
The interventions under investigation include: Pillow Condition 1 (OTHER), Pillow Condition 2 (OTHER), Heel Foam Pillow (DEVICE), Offloading Device A (DEVICE), Offloading Device B (DEVICE).
Who is sponsoring clinical trial NCT02811965?
This trial is sponsored by DeRoyal Industries, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02811965 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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