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.
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
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.
- Conditions
- Foot Injuries, Ankle Injuries
- 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 group | Role | What they receive |
|---|---|---|
| New durable medical equipment (DME) walking boot | Active comparator | A 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 boot | Experimental | A 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.
Rate of skin based complications (%)
blisters, sores, erythema, rashes
Measured: 1-2 weeks after boot receipt
Rate of skin based complications (%)
blisters, sores, erythema, rashes
Measured: 4-weeks after boot receipt
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.
- First posted17 Dec 2025
- Study start25 Sep 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot InjuriesStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Bellaire, University of Utah
- Investigators
- Laura Bellaire, M.D., Principal investigator, University of Utah Orthopaedics
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial to Determine the Safety of Reusing Walking Boot Components for Patients Recovering From Acute Foot and Ankle Injuries
- ClinicalTrials.gov ID
- NCT07287969
- Acronym / sponsor ID
- 176418
- Conditions
- Foot Injuries, Ankle Injuries
- Keywords
- Reusing Walking Boot, PROCARE MaxTrax 2.0, Air, Tall, PROCARE MiniTrax, Safety
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New durable medical equipment (DME) walking boot | Active comparator | Device: New durable medical equipment (DME) walking bootA patient will be randomized to the "new" boot arm of the study. |
| Re-used durable medical equipment (DME) walking boot | Experimental | Device: Re-used durable medical equipment (DME) walking bootA patient will be randomized to the "reuse" boot arm of the study. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New durable medical equipment (DME) walking bootAlso: PROCARE MaxTrax 2.0, Air, Tall, PROCARE MiniTraxThe patient will be randomized and fitted with their designated DME boot. | Device | New durable medical equipment (DME) walking boot |
| Re-used durable medical equipment (DME) walking bootAlso: PROCARE MaxTrax 2.0, Air, Tall, PROCARE MiniTraxThe patient will be randomized and fitted with their designated DME boot. | Device | Re-used durable medical equipment (DME) walking boot |
Primary outcome
Rate of skin based complications (%)
Time frame: 1-2 weeks after boot receipt
blisters, sores, erythema, rashes
Rate of skin based complications (%)
Time frame: 4-weeks after boot receipt
blisters, sores, erythema, rashes
Rate of skin based complications (%)
Time frame: 3 months after boot receipt
blisters, sores, erythema, rashes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Bellaire, M.D. principal investigator
University of Utah Orthopaedics
1 site in 1 country: see every site and its status.
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.