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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT07287969
Status
Enrolling By Invitation

Conditions

  • Ankle Injuries
  • Foot Injuries

Eligibility Criteria

Sex
ALL
Age
1 Year - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • New durable medical equipment (DME) walking boot — DEVICE
    The patient will be randomized and fitted with their designated DME boot.
  • Re-used durable medical equipment (DME) walking boot — DEVICE
    The patient will be randomized and fitted with their designated DME boot.

Study Details

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.

Key Dates

Start date
Sep 25, 2024
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: New durable medical equipment (DME) walking boot
    A patient will be randomized to the "new" boot arm of the study.
  • Experimental: Re-used durable medical equipment (DME) walking boot
    A patient will be randomized to the "reuse" boot arm of the study.

Primary Outcome Measure

Rate of skin based complications (%) [ Time Frame: 1-2 weeks after boot receipt ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Utah OrthopedicsSalt Lake CityUtah84108-

Find similar trials in Salt Lake City, UT

By research site
University of Utah Orthopedics· Salt Lake City, UT

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