Actively Recruiting
Wheeling to Healing: A Novel Method for Improving Healing of Diabetic Foot Ulceration
Led by University of Saskatchewan · Updated on 2024-05-09
68
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
Sponsors
U
University of Saskatchewan
Lead Sponsor
S
Saskatchewan Health Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Wheeling to Healing: A Novel Method for Improving Healing of Diabetic Foot Ulceration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Currently under physician care for a diabetic foot ulcer on one foot
- Willing and able to sign informed consent
- Cognitively functional
- Have access to a telephone
- Weigh no more than 300 pounds
- Have at least one palpable foot pulse
- Have a neuropathic plantar diabetic foot ulcer classified as grade 1A (superficial, not extending to tendon, capsule, or bone) using the University of Texas Diabetic Foot Wound Classification System
You will not qualify if you...
- Coronary or cerebrovascular disease events within the past six months
- Uncontrolled, severe medical conditions that increase risk of adverse events, such as severe congestive heart failure, angina pectoris, or obstructive pulmonary disease
- Uncontrolled neurologic or psychiatric disorders
- Active infection
- Significant ulcers or infections on both lower limbs
- Wheelchair dependence prior to ulcer formation
- Absence of pedal pulse
- Any condition limiting ability to walk or stand without pain or discomfort, including shortness of breath, fatigue, angina, or severe arthritis
- Use of medications that impair balance or judgment
- Other conditions deemed exclusionary by investigators or primary care providers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N2Z4
Actively Recruiting
Research Team
A
Audrey R Zucker-Levin, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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