NCT04257565

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

Wheeling to Healing: Does Wheeled Knee Walker Use Improve Wound Healing, Improve Quality of Life and Decrease Risk of Contralateral Ulceration in People With Diabetic Foot Ulcers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The rate of diabetes in Saskatchewan is among the highest of all Canadian provinces with a prevalence of 8.5% in 2015 with an expected rise to 11.1% in 2025. Diabetic foot ulcers (DFU) are a common complication and the leading cause of lower limb amputation worldwide. Treatment for DFU include casts, braces, crutches and walkers to remove pressure (offload) from the ulcer. These interventions, when not rejected, foster a sedentary lifestyle which negatively impacts function and quality of life. Also, crutches and walkers may increase risk of ulceration of the sound foot as the arms are often not strong enough to support the body weight when stepping. The wheeled knee walkers (WKW) is a relatively new walking aid that allows total offloading of one foot, requires less physical exertion, and is more stable than crutches or walkers. The purpose of this research is to determine if a WKW would improve wound healing, quality of life, and physical function while decreasing the risk of sound foot ulceration in people with DFU. To explore these objectives we will recruit people with DFU who are under the care of a vascular surgeon, perform standardized baseline measures for each objective, provide a WKW to half of the participants and then re-evaluate all objectives at 6 and 12 weeks. The results will help guide treatment and inform decision making to optimize care. Further, the project will establish an interdisciplinary collaborative research program for future projects to improve health and advance knowledge.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-05-01
• Primary completion: 2025-03-31
• Completion: 2025-09-30
• First posted: 2020-02-06
• Last updated: 2024-05-09

Locations

1 site across 1 country: Canada