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

NACompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

November 30, 2016

Study Completion Date

November 30, 2016

Conditions
Heel Pressure Ulceration Prevention Strategies
Interventions
OTHER

Pillow Condition 1

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

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.

DEVICE

Heel Foam Pillow

An economy heel offloading device constructed of egg shell foam.

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.

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

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.

Trial Locations (1)

37923

Lincoln Memorial University; Cedar Bluff Campus, Knoxville

All Listed Sponsors
collaborator

Lincoln Memorial University

OTHER

lead

DeRoyal Industries, Inc.

INDUSTRY

NCT02811965 - Evaluation of Heel Offloading Devices for Reducing Heel Contact Pressures in Healthy Volunteers | Biotech Hunter | Biotech Hunter