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

NCT ID: NCT02811965

Last Updated: 2018-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-11-30

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.

Conditions

Heel Pressure Ulceration Prevention Strategies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Control

Pressure mapping is performed without a heel offloading intervention applied.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Pillow Condition 1

Pressure mapping is performed with the Pillow condition 1 intervention applied to the heel.

Group Type: EXPERIMENTAL

Pillow Condition 1

Intervention Type: OTHER

The heel is offloaded by placing the heel on a standard hospital pillow.

Pillow Condition 2

Pressure mapping is performed with the Pillow condition 2 applied to the heel.

Group Type: EXPERIMENTAL

Pillow Condition 2

Intervention Type: OTHER

The heel is offloaded by placing a standard hospital pillow under the calf suspending the heel above the hospital bed mattress.

Heel Foam Pillow

Pressure mapping is performed with the heel foam pillow device applied to the heel.

Group Type: EXPERIMENTAL

Heel Foam Pillow

Intervention Type: DEVICE

An economy heel offloading device constructed of egg shell foam.

Offloading Device A

Pressure mapping is performed with Offloading Device A applied to the heel.

Group Type: EXPERIMENTAL

Offloading Device A

Intervention Type: DEVICE

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 B

Pressure mapping is performed with Offloading Device B applied to the heel.

Group Type: EXPERIMENTAL

Offloading Device B

Intervention Type: DEVICE

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 C

Pressure mapping is performed with Offloading Device C applied to the heel.

Group Type: EXPERIMENTAL

Offloading Device C

Intervention Type: 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.

Interventions

Pillow Condition 1

The heel is offloaded by placing the heel on a standard hospital pillow.

Intervention Type: 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.

Intervention Type: OTHER

Heel Foam Pillow

An economy heel offloading device constructed of egg shell foam.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

PRUventor® Heel Off-loading Device

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lincoln Memorial University

OTHER

Sponsor Role: collaborator

DeRoyal Industries, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Savage, DNP

Role: PRINCIPAL_INVESTIGATOR

Lincoln Memorial University

Locations

Lincoln Memorial University; Cedar Bluff Campus

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

534

Identifier Type: -

Identifier Source: org_study_id