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

January 4, 2018 updated by: DeRoyal Industries, Inc.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37923
        • Lincoln Memorial University; Cedar Bluff Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • PRUventor® Heel Off-loading Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 minutes of 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.
5 minutes of pressure mapping

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DeRoyal Industries, Inc.

Collaborators

Lincoln Memorial University

Investigators

  • Principal Investigator: Jennifer Savage, DNP, Lincoln Memorial University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (ESTIMATE)

June 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 8, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 534

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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