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Foot InjuriesNCT07287969

The Safety of Reusing Walking Boot Components for Patients Recovering From Acute Foot and Ankle Injuries

A study testing New durable medical equipment (DME) walking boot and Re-used durable medical equipment (DME) walking boot in people with Foot Injuries and Ankle Injuries, run by University of Utah at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 17 years
Conditions the study is for
Foot Injuries, Ankle Injuries
What is being tested?
New durable medical equipment (DME) walking boot and Re-used durable medical equipment (DME) walking boot
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
25 Sep 2024to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • University of Utah Orthopedics

    Salt Lake City, Utah, 84108

Other trials in United States

About this study

Official title: Prospective Randomized Trial to Determine the Safety of Reusing Walking Boot Components for Patients Recovering From Acute Foot and Ankle Injuries

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.

Read the detailed description

The designation of an item as "durable medical equipment" (DME) implies the item is designed to be long-lasting and hold up to prolonged use. In practice, however, many DME items are utilized for a single patient after a single injury or procedure. This is particularly true in pediatric care, where patients are growing, and saving the item for later use is unlikely to maintain appropriate fit for the older child.

Walking boots, also termed CAM boots, are prescribed frequently in pediatric orthopaedic clinics across the country. These boots provide support, comfort, and immobilization while also allowing for removal to allow patients to begin wound care, range of motion exercises, and bathing. They provide a valuable transitional stage between casting and splinting and resumption of typical, unsupported ambulation and other activities. While differences in design exist between vendors, the vast majority of walking boots have a modular design including a base/sole attached to rigid medial and lateral posts, soft fabric/Velcro straps, and a soft cushioned liner. This modular design lends itself to opportunities for reuse and refurbishment, yet this is rarely considered.

Boots and other DME contribute considerable costs to patients and family. The costs of DME items vary widely, with simple items like canes costing less than $100 and custom items like power wheelchairs costing more than $5,000. In total, US spending on mobility-related DME items reached $1.5 billion in 2001, a figure that has likely grown exponentially over the past 2 decades due to inflation and supply chain shortages. Patients and health systems both encounter DME related charges, and health insurance payments for DME vary widely across payors. Provision of DME is a frequent cause of hospital discharge delays, contributing to lengthier hospital stays, prolonged immobilization, and greater cost of care. This is particularly true for low-income and uninsured families, perpetuating discrepancies in health equity and access to care. Charity care programs facilitate access to DME in some states, however Anti-Kickback statutes and other policies obstruct provision of free equipment in many systems.

Studies have shown that patients get little to no information related to appropriate reuse, recycling and other disposal programs for walking boots and other DME. Interview based studies suggest that equipment disposal options are simply not a part of discussions with patients-time with patients can be limited, time spent obtaining and fitting the DME item can be prolonged leaving little time to discuss other topics, and discussing disposal methods has been cited as sending a potential "mixed message" regarding the importance of the DME item itself.

Larger, more costly DME items owned by health systems including hospital beds and wheelchairs tend to be maintained by hospitals and care facilities so long as they can function without posing a threat to patient or staff safety. This is typically done through informal policies and guidance, borrowing from existing environmental service practices within a given facility for equipment cleaning and maintenance. Rental programs are available in many health systems for such items, with infrastructure to support their inspection, cleaning, and refurbishment as well as delivery and pick-up for some.

Hospitals that reuse DME see the double benefit of reduced budgets for purchasing new items and reduced costs of disposal-American health systems have been found to dispose of up to 10 billion dollars in equipment and supplies every year. Any fractional reduction in such practices would considerably reduce both cost and waste burden.

Smaller, patient-owned DME items, on the other hand, are not typically included in such reuse or rental programs. Instead, the majority of these items end up in landfills. They arrive in landfills either via residential or health system waste streams, depending on whether patients bring them back to their physician's office or leave them at home for a period before ultimately throwing them away. Some patients and clinics seek out alternative solutions including donation programs, parts salvage, recycling of core materials, and informally sharing the items with friends, family, and neighbors in need.

DME donation programs have emerged out of community charities, nonprofit organizations, and few health systems. Typically, specified items are collected informally from interested patients, then sent to low resource patients and communities in need without formalized or regulated inspection or reprocessing. Donation recipients can be local or represent communities abroad with partner organizations and/or medical mission programs. While generally well-intentioned, such programs beg the question-if reused DME items are good enough for these recipients, mustn't it also be good enough for everyone? "Why should someone who's poor get recycled equipment instead of new equipment" simply because they are impoverished?.

A further critical reason the medical community must reconsider the current practice of using of walking boots and other DME as single use items is related to waste. Attention to and scrutiny of the waste generated in and by health systems is growing, as is the recognition that orthopaedic surgeons and other healthcare practitioners have the ability to personally reduce the environmental harm caused by their practices. Like other waste reduction efforts, DME reuse programs should comprise part of hospital strategies to provide environmentally sustainable healthcare to communities.

While single use devices (SUDs) have seen a surge in popularity and adoption in the US, particularly with heightened concerns about contamination in the wake of the COVID pandemic, such items generate tremendous amounts of waste for which hospital systems are currently responsible.

Their increased utilization has also shifted hospital budgets and habits away from reusable items and bettering reprocessing pathways. There is a growing market for and interest in reprocessing SUDs and their components in the operating room setting, and regulations are shifting to support such efforts in the US and abroad. If physicians and their patients express interest in and willingness to utilize reuse programs, it is likely similar regulatory shifts will emerge to support such patterns in the realm of DME.

From an environmental stewardship standpoint, further study is needed surrounding optimal reuse pathways for walking boots and other DME. Life cycle assessments, which provide an estimate of the impact of specific products from cradle to grave, will inform opportunities to promote durability of reusable components and recycling or decomposition potential of those components (liners, straps) suited for only a single use. The sentiment, however, prevails that DME reuse and recycling represents the "right thing to do," and the only way to change routine behaviors is by reinforcing a sense of collective responsibility for the responsible and appropriate management of limited resources. Advancing research on the reuse potential of DME and other medical products is a necessary step in changing systems and organizational culture to promote the use of such items "for the duration of the lifespan for which they were built".

The DME specific boot the investigators use in the clinic is the PROCARE MaxTrax 2.0, Air, Tall or PROCARE MiniTrax depending on age and size of child.

Being tested
New durable medical equipment (DME) walking boot, Re-used durable medical equipment (DME) walking boot
Keywords
Reusing Walking Boot, PROCARE MaxTrax 2.0, Air, Tall, PROCARE MiniTrax, Safety
Medical subject headings
Foot Injuries, Ankle Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • New durable medical equipment (DME) walking bootDevice

    Also called PROCARE MaxTrax 2.0, Air, Tall, PROCARE MiniTrax

    The patient will be randomized and fitted with their designated DME boot.

  • Re-used durable medical equipment (DME) walking bootDevice

    Also called PROCARE MaxTrax 2.0, Air, Tall, PROCARE MiniTrax

    The patient will be randomized and fitted with their designated DME boot.

Study groups in NCT07287969
Study groupRoleWhat they receive
New durable medical equipment (DME) walking bootActive comparatorA patient will be randomized to the "new" boot arm of the study.
Receives: Device: New durable medical equipment (DME) walking boot
Re-used durable medical equipment (DME) walking bootExperimentalA patient will be randomized to the "reuse" boot arm of the study.
Receives: Device: Re-used durable medical equipment (DME) walking boot

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of skin based complications (%)

    blisters, sores, erythema, rashes

    Measured: 1-2 weeks after boot receipt

  2. Rate of skin based complications (%)

    blisters, sores, erythema, rashes

    Measured: 4-weeks after boot receipt

  3. Rate of skin based complications (%)

    blisters, sores, erythema, rashes

    Measured: 3 months after boot receipt

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2025
  2. Study start25 Sep 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07287969
Sponsor's protocol ID
176418
Status last verified
Aug 2026
First submitted
14 Dec 2025
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing New durable medical equipment (DME) walking boot and Re-used durable medical equipment (DME) walking boot in people with Foot Injuries and Ankle Injuries, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of skin based complications (%) (time frame: 1-2 weeks after boot receipt). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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