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

Part of paid clinical trials in Northfield, Illinois.

Sponsor
Medline Industries
Study ID
NCT07734220
Status
Completed

Conditions

  • Pressure Injuries

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • HeelMedix Basic & EHOB Waffle — DEVICE
    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.

Study Details

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

Key Dates

First listed
Jul 29, 2026
Start date
Jul 8, 2026
Status verified
Jul 2026
Primary completion
Jul 22, 2026
Completion
Jul 22, 2026

Study Design

Enrollment
25 participants (actual)

Primary Outcome Measure

To evaluate heel offloading capabilities of two heel protection boot devices [ Time Frame: 3-6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Medline Industries, LPNorthfieldIllinois60093-

Find similar trials in Northfield, IL

By research site
Medline Industries, LP· Northfield, IL

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