ClinicalTrials.gg
Enrolling by invitationNCT07287969Updated Aug 13, 2026

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

An interventional study of New durable medical equipment (DME) walking boot and Re-used durable medical equipment (DME) walking boot in Foot Injuries and Ankle Injuries, sponsored by University of Utah. Enrolling by invitation at 1 site in United States. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by University of Utah · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Sep 2024, registered Dec 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
1 Year to 17 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Foot Injuries
  • Ankle Injuries

Keywords

  • Reusing Walking Boot
  • PROCARE MaxTrax 2.0, Air, Tall
  • PROCARE MiniTrax
  • Safety
03

In context

Foot Injuries

60 studies on the registry are indexed under Foot Injuries; 15 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 46 interventional studies indexed under Foot Injuries.

Browse Foot Injuries studies →

Lead sponsor

University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.

Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with ongoing infection, skin lesions, or wounds
  • patients
  • Patients with autism or behavioral concerns
  • Non ambulatory patients
  • Fitted and provided in the operating room or inpatient settings
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    New durable medical equipment (DME) walking boot

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

    Device: New durable medical equipment (DME) walking boot

  • Experimental
    Re-used durable medical equipment (DME) walking boot

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

    Device: Re-used durable medical equipment (DME) walking boot

Interventions

  • DeviceNew durable medical equipment (DME) walking boot

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

    Also known as: PROCARE MaxTrax 2.0, Air, Tall, PROCARE MiniTrax

  • DeviceRe-used durable medical equipment (DME) walking boot

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

    Also known as: PROCARE MaxTrax 2.0, Air, Tall, PROCARE MiniTrax

06

What researchers measure

Primary outcomes

  1. Rate of skin based complications (%)

    blisters, sores, erythema, rashes

    Time frame: 1-2 weeks after boot receipt

  2. Rate of skin based complications (%)

    blisters, sores, erythema, rashes

    Time frame: 4-weeks after boot receipt

  3. Rate of skin based complications (%)

    blisters, sores, erythema, rashes

    Time frame: 3 months after boot receipt

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2024 (actual). Primary completion is estimated for Sep 2027, 36 months after the start.

Of 26 interventional studies with no phase under Foot Injuries, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 36 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 14, 2025
First posted
Dec 17, 2025
StartActual
Sep 25, 2024
Primary completionEst.
Sep 2027
CompletionEst.
Sep 2027
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07287969
Lead sponsor
University of Utah
Responsible party
Laura Bellaire (Principle Investigator, University of Utah) — Principal investigator
First posted
Dec 17, 2025
Start date
Sep 25, 2024
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Aug 13, 2026

Study contacts

Laura Bellaire, M.D.
principal investigator · University of Utah Orthopaedics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion