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

RECRUITINGN/ASponsored by University of Saskatchewan
Actively Recruiting
PhaseN/A
SponsorUniversity of Saskatchewan
Started2022-05-01
Est. completion2025-03-31
Eligibility
Age18 Years+
Healthy vol.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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* ≥ 18 years old
* currently under physician care for a DFU of one foot
* willing and able to sign informed consent
* cognitively functional
* have access to a telephone
* weigh no more than 300lbs as this is the weight limitation of the wheeled knee walker
* have at least one palpable foot pulse
* have a neuropathic plantar DFU corresponding to grade 1A (superficial, not extending to tendon, capsule, or bone) using the University of Texas Diabetic Foot Wound Classification System

Exclusion Criteria:

* coronary or cerebrovascular disease events within the past six months
* uncontrolled, severe medical conditions that place the subject at high risk for adverse events, including but not limited to severe congestive heart failure, angina pectoris, obstructive pulmonary disease
* uncontrolled neurologic or psychiatric disorders
* active infection
* significant ulcers or infections of both lower limbs
* those who have been wheelchair dependent prior to ulcer formation
* absence of pedal pulse
* any condition that would limit the ability to ambulate or stand without pain or discomfort, including but not limited to shortness of breath, fatigue, angina, severe arthritis
* medication use that causes impaired balance or judgment
* other circumstances at the investigators' and primary care providers' discretion.

Conditions2

DiabetesDiabetes Mellitus

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