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

Not Applicable

Completed

Conditions: Heel Pressure Ulceration Prevention Strategies

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

Registration Number: NCT02811965

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pillow Condition 2	Pillow Condition 2	Pressure mapping is performed with the Pillow condition 2 applied to the heel.
Offloading Device B	Offloading Device B	Pressure mapping is performed with Offloading Device B applied to the heel.
Pillow Condition 1	Pillow Condition 1	Pressure mapping is performed with the Pillow condition 1 intervention applied to the heel.
Heel Foam Pillow	Heel Foam Pillow	Pressure mapping is performed with the heel foam pillow device applied to the heel.
Offloading Device C	Offloading Device C	Pressure mapping is performed with Offloading Device C applied to the heel.
Offloading Device A	Offloading Device A	Pressure mapping is performed with Offloading Device A applied to the heel.

Primary Outcome Measures

Name	Time	Method
Peak Pressure Index on the Heel	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.
Average Contact Force Exerted on the Heel	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

Secondary Outcome Measures