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

DeRoyal Industries

Status: Completed

Conditions: Heel Pressure Ulceration Prevention Strategies

Treatments: Device: Heel Foam Pillow; Device: Offloading Device A; Other: Pillow Condition 2; Device: Offloading Device B; Device: Offloading Device C; Other: Pillow Condition 1

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02811965

534

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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21 participants in 7 patient groups

Control

No Intervention group

Description:

Pressure mapping is performed without a heel offloading intervention applied.

Pillow Condition 1

Experimental group

Description:

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

Treatment:

Other: Pillow Condition 1

Pillow Condition 2

Experimental group

Description:

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

Treatment:

Other: Pillow Condition 2

Heel Foam Pillow

Experimental group

Description:

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

Treatment:

Device: Heel Foam Pillow

Offloading Device A

Experimental group

Description:

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

Treatment:

Device: Offloading Device A

Offloading Device B

Experimental group

Description:

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

Treatment:

Device: Offloading Device B

Offloading Device C

Experimental group

Description:

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

Treatment:

Device: Offloading Device C