Evaluation of Two Heel Protection Devices to Assess Off-loading Via Pressure Mapping.

July 24, 2026 updated by: Medline Industries

Evaluation of Two Heel Protection Devices to Assess Off-loading Via Pressure Mapping

The goal of this trial is to compare heel off-loading capabilities of two products

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pressure injuries to the heel remain a major concern for immobile or limited mobility patients, as the heel is one of the highest risk sites for tissue breakdown. Offloading boots are widely used to redistribute lower extremity pressure and minimize concentrated forces at the heel. Internal Medline studies and industry literature reinforce the clinical relevance of pressure mapping to quantify heel offloading effectiveness across devices. Prior work has shown that heel offloading boots can differ widely in their ability to reduce pressure at the heel and ankle joint region. This study will quantitatively compare the heel off-loading capabilities of the Medline HeelMedix® Basic Heel Boot (hereafter referred to as HeelMedix® Basic) and the EHOB Foot Waffle Protector (hereafter referred to as EHOB Waffle) using pressure mapping in healthy volunteers. The data from this study design will allow for a comparative assessment of the heel offloading capabilities between two heel offloading boots.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Northfield, Illinois, United States, 60093
        • Medline Industries, LP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Total number of participants, N=25

Description

Inclusion Criteria:

  • Individual is ≥ 22 years old
  • Self-reported to be in healthy condition.
  • Able to remain seated on a hard surface such as the floor and wear a heel protectant boot for at least thirty minutes.
  • Able to understand and willing to carry out instructions for this study.
  • Has a calf circumference of 11-19 inches

Exclusion Criteria:

  • Self-reported to have pre-existing pathology associated with lower extremities
  • Individual has a calf circumference of less than 11 inches or greater than 19 inches
  • Individual is employed in a division of Medline Industries, LP under which the study product(s) are developed
  • Individual is sensitive to the materials of the study product(s)
  • Individual is considered inappropriate for inclusion by the principal investigator
  • Medline Contractors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate heel offloading capabilities of two heel protection boot devices
Time Frame: 3-6 months
The primary endpoint will be the percentage change in peak and average pressures in the lower extremity (measuring heel, calf and combination)
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medline Industries

Investigators

  • Principal Investigator: Gregory J Gomez, RN BSN MPH, Medline Industries, LP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2026

Primary Completion (Actual)

July 22, 2026

Study Completion (Actual)

July 22, 2026

Study Registration Dates

First Submitted

July 24, 2026

First Submitted That Met QC Criteria

July 24, 2026

First Posted (Actual)

July 29, 2026

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 24, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-2025-DIV75-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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