Walking Boot Reuse for Foot and Ankle Injuries

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Infection, Immunosuppressed, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Laura Bellaire, M.D.

Principal Investigator

University of Utah Orthopaedics

Are You a Good Fit for This Trial?

This trial is for patients recovering from acute foot and ankle injuries who are in need of a walking boot. There's no specific inclusion or exclusion criteria provided, so it appears open to individuals requiring this type of durable medical equipment (DME) for their recovery.

Inclusion Criteria

I am recovering from a recent foot or ankle injury.

I will use the boot for less than 12 weeks.

I am old enough to walk.

Exclusion Criteria

I cannot walk by myself.

Fitted and provided in the operating room or inpatient settings

I do not have any current infections, skin lesions, or wounds.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either a new or reused walking boot and monitored for safety and effectiveness

3 months

Regular visits for monitoring

Follow-up

Participants are monitored for skin-based complications such as blisters, sores, erythema, and rashes after treatment

3 months

What Are the Treatments Tested in This Trial?

Trial Overview

The study is testing the safety of reusing components from walking boots compared to using new ones. It also aims to determine how many times boot components can be reused before they fail, with an eye on reducing waste and promoting reusable DME products.

How Is the Trial Designed?

Group I: Re-used durable medical equipment (DME) walking boot Experimental Treatment 1 Intervention

A patient will be randomized to the "reuse" boot arm of the study.

Group II: New durable medical equipment (DME) walking boot Active Control 1 Intervention

A patient will be randomized to the "new" boot arm of the study.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+