An observational study in Pressure Injuries, sponsored by Medline Industries. Completed at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Medline Industries · Observational
The goal of this trial is to compare heel off-loading capabilities of two products
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.
545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.
This study's enrollment of 25 is below the median of 138 across 110 observational studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Medline Industries is the lead sponsor of 39 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 14 (93%) have results posted.
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Total number of participants, N=25
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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.
To evaluate heel offloading capabilities of two heel protection boot devices
The primary endpoint will be the percentage change in peak and average pressures in the lower extremity (measuring heel, calf and combination)
Time frame: 3-6 months
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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