Pressure Injuries
Conditions
Keywords
pressure mapping
Brief summary
The goal of this trial is to compare heel off-loading capabilities of two products
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.
Interventions
DEVICEHeelMedix Basic & EHOB Waffle
Participants will then have a baseline pressure mapping measurement taken, where they will be instructed to outstretch their right leg in front of them onto the BPMS pressure mat. The baseline peak and average pressures of the lower extremity in the heel, calf and combination of heel and calf as shown on the TekScan software connected to the mat will be recorded on the designated CRF. Pressure minimum and standard deviation will also be recorded. Once baseline measurements are complete, the first of two study devices will be applied to the participant, and they will place their leg back on the pressure mat in the same manner as the baseline measurement. Peak and average pressures of the lower extremity while wearing the first study device, in the heel, calf and combination of heel and calf as shown on the TekScan software connected to the mat will be recorded on the designated CRF. Pressure minimum and standard deviation will also be recorded. Steps will be repeated for 2nd device.
Sponsors
Medline Industries
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate heel offloading capabilities of two heel protection boot devices | 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGregory J Gomez, RN BSN MPH
Medline Industries, LP
Outcome results
None listed