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Wheeling to Healing: A Novel Method for Improving Healing of Diabetic Foot Ulceration

NCT04257565 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-05-09

No results posted yet for this study

Summary

The increasing incidence of diabetes and high risk of amputation makes prevention and successful treatment of DFU of vital importance. A relatively new device, the wheeled knee walker, allows total offloading of the affected foot and, when compared to traditional walking aids such as crutches and walkers, requires significantly less physical exertion, is easier to use, and affords more stability. Its potential benefit to improve wound healing, impact physical function and quality of life in people with DFU is not yet known. Therefore, the goal of this research is to determine whether providing a wheeled knee walker to people with diabetic foot ulcers improves clinical outcomes and quality of life when compared to usual and customary care.

Conditions

Interventions

DEVICE

Wheeled Knee Walker

The Wheeled Knee Walker allows total offloading of a healing limb and may diminish excessive force on the contralateral limb.

OTHER

Usual and Customary Care

This group will receive usual and customary care for treatment of their diabetic foot ulcer

Sponsors & Collaborators

  • Saskatchewan Health Research Foundation

    collaborator OTHER

  • University of Saskatchewan

    lead OTHER

Principal Investigators

  • Audrey R Zucker-Levin, PhD · University of Saskatchewan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2025-03-31
Completion
2025-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT04257565 on ClinicalTrials.gov