The Safety of Reusing Walking Boot Components for Patients Recovering From Acute Foot and Ankle I… (NCT07287969) | Clinical Trial Compass
By InvitationNot Applicable
The Safety of Reusing Walking Boot Components for Patients Recovering From Acute Foot and Ankle Injuries
United States60 participantsStarted 2024-09-25
Plain-language summary
The investigators primary purposes is to determine the safety of reusing a specific durable medical equipment (DME) item (walking boots) components for patients recovering from acute foot and ankle injuries.
The investigators secondary purpose is to determine the number of reuse episodes specific walking boot components can endure without increased failure rates.
To support further study of DME reuse, product design, and advocate for evolving regulations that promote waste reduction via development of reusable DME products in the US.
Who can participate
Age range
1 Year – 17 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:
* Patient is of ambulatory age
* Patient is ambulatory at baseline (i.e. prior to injury or intervention)
* Patient is recovering from an acute foot or ankle injury (bony or soft tissue)
* Patients expected to utilize the boot for \<12 weeks total
* Prescribed in the outpatient clinic setting only
Exclusion Criteria:
* Patients with ongoing infection, skin lesions, or wounds
* Immunosuppressed patients
* Patients with autism or behavioral concerns
* Non ambulatory patients
* Fitted and provided in the operating room or inpatient settings
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.