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

NCT02811965 | Completed Results

• 1 other identifier: 534
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

heel; pressure ulcer; pressure mapping

Outcome Measures

Primary Outcomes (2)

• Average Contact Force Exerted on the Heel

  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

  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

Study Arms (7)

Control

NO INTERVENTION

Pressure mapping is performed without a heel offloading intervention applied.

Pillow Condition 1

EXPERIMENTAL

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

Other: Pillow Condition 1

Pillow Condition 2

EXPERIMENTAL

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

Other: Pillow Condition 2

Heel Foam Pillow

EXPERIMENTAL

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

Device: Heel Foam Pillow

Offloading Device A

EXPERIMENTAL

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

Device: Offloading Device A

Offloading Device B

EXPERIMENTAL

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

Device: Offloading Device B

Offloading Device C

EXPERIMENTAL

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

Device: Offloading Device C

Interventions

Pillow Condition 1 OTHER

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

Pillow Condition 1

Pillow Condition 2 OTHER

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

Pillow Condition 2

Heel Foam Pillow DEVICE

An economy heel offloading device constructed of egg shell foam.

Heel Foam Pillow

Offloading Device A 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 A

Offloading Device B 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 B

Offloading Device C 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.

Also known as: PRUventor® Heel Off-loading Device

Offloading Device C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• No musculoskeletal injury in the past month
• Body Mass Index (BMI) between 18.5 and 39.9

You may not qualify if:

• 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

Sponsors & Collaborators

• DeRoyal Industries, Inc.: lead
• Lincoln Memorial University: collaborator

Study Sites (1)

Lincoln Memorial University; Cedar Bluff Campus

Knoxville, Tennessee, 37923, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Jennifer Savage, DNP, APN, FNP-BC
• Organization: Lincoln Memorial University

jennifer.savage@lmunet.edu

Study Officials

• Jennifer Savage, DNP

  Lincoln Memorial University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each research subject will have pressure mapping performed on his or her right foot in the 7 conditions described for each study arm to determine the contact forces experienced by the heel in each off-loading condition. Each intervention will be randomly applied.

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 23, 2016
• Study Start: June 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 8, 2018
• Results First Posted: December 7, 2017

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)