Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Heel Offloading Devices for Reducing Heel Contact Pressures in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02811965
Recruitment Status : Completed
First Posted : June 23, 2016
Results First Posted : December 7, 2017
Last Update Posted : January 8, 2018
Sponsor:
Collaborator:
Lincoln Memorial University
Information provided by (Responsible Party):
DeRoyal Industries, Inc.

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
Heel Pressure Ulceration Prevention Strategies Other: Pillow Condition 1 Other: Pillow Condition 2 Device: Heel Foam Pillow Device: Offloading Device A Device: Offloading Device B Device: Offloading Device C Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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.
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 : June 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

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 Name: PRUventor® Heel Off-loading Device




Primary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811965


Locations
Layout table for location information
United States, Tennessee
Lincoln Memorial University; Cedar Bluff Campus
Knoxville, Tennessee, United States, 37923
Sponsors and Collaborators
DeRoyal Industries, Inc.
Lincoln Memorial University
Investigators
Layout table for investigator information
Principal Investigator: Jennifer Savage, DNP Lincoln Memorial University
Layout table for additonal information
Responsible Party: DeRoyal Industries, Inc.
ClinicalTrials.gov Identifier: NCT02811965    
Other Study ID Numbers: 534
First Posted: June 23, 2016    Key Record Dates
Results First Posted: December 7, 2017
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by DeRoyal Industries, Inc.:
heel
pressure ulcer
pressure mapping
Additional relevant MeSH terms:
Layout table for MeSH terms
Ulcer
Pathologic Processes