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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Wound Healing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •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.
结局指标
主要结局
Wound Healing
时间窗: 12 Weeks
The wound will be measured using Image J, open source digital imaging software developed at the National Institutes of Health (NIH) to measure wound area of the target wound, in mm2 (the largest foot wound if multiple wounds are present). Image J software has been used specifically for the measurement of diabetic foot ulcers with very high inter- and intra-rater reliability (p=0.997 and 0.999 respectively) \[1\]. The wound will be traced on acetate paper using a fine permanent marker for use in Image J and a standard distance photograph of the wound will be taken to document wound bed characteristics after physician debridement to healthy granulating tissue or healthy bleeding tissue is reached \[1, 2\]. The physician will record depth at its greatest point using a probe at the time of debridement, assess wound condition (improving, stable, or deteriorating), and the presence or absence of undermining or tunneling. A completely healed wound has complete epithelialization.
次要结局
- Physical Function(12 weeks)
- Quality of Life: The Diabetic Foot Ulcer Scale (DFS)(12 weeks)
- Risk of ulceration of the sound foot(12 weeks)
研究者
Audrey Zucker-Levin
Professor
University of Saskatchewan