The Effect of Exercise on Wound Healing in People With Diabetes Undergoing Off-loading Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Wound measurement size
研究概览
简要总结
This study seeks to establish the effect of adding exercise to off-loading interventions on the healing time for people with diabetes mellitus and a foot ulcer. Hypothesis: Consistent with the literature, results are expected to resemble the accelerated healing seen when older adults exercised in the presence of wounds.
详细描述
The purpose of this project is to establish the effect of the addition of exercise to an off-loading intervention on the healing time for people with diabetes mellitus and a foot ulcer.
While benefits of physical activity and exercise are clear, the benefit of exercise on wound healing in individuals with diabetes has not been elucidated. It is critical to better understand how prescribed exercise effects the healing speed in patients receiving wound care with appropriate off-loading. If exercise does decrease healing time, the benefit to the patient may include lower cost, decreased risk of infection, decreased burden on a caregiver, and improved quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The outcome assessor will be unaware of how much the participant participated in the exercise program. Exercise will occur away from the treatment area so that the care provider will be unaware of whether or not a patient is participating in the study.
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
- •Have diabetes
- •Have an active plantar ulceration
- •With or without peripheral neuropathy
- •Able to safely exercise
- •Receiving care for their plantar ulceration, including off-loading
排除标准
- •Presence of an untreated infection, osteomyelitis, or gangrene
结局指标
主要结局
Wound measurement size
时间窗: Measurements of wound will be taken up to 12 weeks or until wound closure occurs, whichever is first.
Charts will be reviewed for normal wound measurements as is part of standard care. Measurements are expected to be reported as surface area (cm\^2) and/or volume (cm\^3). Wound closure will be defined as epithelialization across the entire wound bed and would be expected to correlate to no surface area or volume of wound being reported.
次要结局
- Summary of Diabetes Self-Care Activities Scale(Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).)
- Physical activity data using an activity monitor (e.g. StepWatch).(Measured at baseline for one week.)
- Vibration sense(Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).)
- Waist circumference(Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).)
- Body Mass Index(Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).)
研究者
Deborah M. Wendland, Ph.D.
Associate Professor
Mercer University