By InvitationNot Applicable

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

United States60 participantsStarted 2024-09-25

Plain-language 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.

Who can participate

Age range1 Year – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: * 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

What they're measuring

Rate of skin based complications (%)

Timeframe: 1-2 weeks after boot receipt

Rate of skin based complications (%)

Timeframe: 4-weeks after boot receipt

Rate of skin based complications (%)

Timeframe: 3 months after boot receipt

Trial details

NCT IDNCT07287969

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

View on ClinicalTrials.gov More Foot Injuries trials