CompletedNot Applicable

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

United States25 participantsStarted 2026-07-08

Plain-language summary

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

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate heel offloading capabilities of two heel protection boot devices

Timeframe: 3-6 months

Trial details

NCT IDNCT07734220

SponsorMedline Industries

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-07-22

View on ClinicalTrials.gov More Pressure Injuries trials

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.