MedTrace Logo

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

NCT07287969 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-17

No results posted yet for this 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.

Conditions

  • Foot Injuries
  • Ankle Injuries

Interventions

DEVICE

Re-used durable medical equipment (DME) walking boot

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

DEVICE

New durable medical equipment (DME) walking boot

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

Sponsors & Collaborators

Principal Investigators

  • Laura Bellaire, M.D. · University of Utah Orthopaedics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-25
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07287969 on ClinicalTrials.gov