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

NCT07734220 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2026-07-29

No results posted yet for this study

Summary

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

Conditions

  • Pressure Injuries

Interventions

DEVICE

HeelMedix 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 & Collaborators

  • Medline Industries

    lead INDUSTRY

Principal Investigators

  • Gregory J Gomez, RN BSN MPH · Medline Industries, LP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-08
Primary Completion
2026-07-22
Completion
2026-07-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07734220 on ClinicalTrials.gov