The Effect of Self-directed Versus Therapist-directed Re-loading on Incidence of Ulcer Recurrence
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence of Ulcer Recurrence
研究概览
简要总结
This study is designed to evaluate if how people are told to return to walking after a skin injury affects whether or not they develop new (recurrence) skin breakdown on their feet. The people in this study will have diabetes and have a recently closed foot ulcer. About half will be specifically told how to return to walking and the other half will be told to return to walking slowly. How people naturally return to walking will also be established.
详细描述
The purpose of this project is to determine the impact of Therapist-directed loading versus self-selected loading on ulcer occurrence and to establish natural loading behavior following diabetic foot ulcer closure.
Eligible participants will be randomized into a group given specific directions from a Therapist to return to walking (i.e. reloading skin following plantar ulceration closure) or a group encouraged to slowly return to walking (self-directed re-loading of the skin following plantar ulceration closure). Following randomization and instruction for re-loading according to group assignment, participants will be assessed every 6 months for walking behavior. Participants will be monitored for ulcer recurrence throughout. Participants will be followed for up to 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will be unaware of in which group the participant was randomized.
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
- •With or without peripheral neuropathy
- •Able to safely exercise
- •Have a recently closed plantar ulceration
排除标准
- •Presence of an open plantar ulceration
- •Presence of an untreated infection
- •Presence of osteomyelitis or gangrene
结局指标
主要结局
Incidence of Ulcer Recurrence
时间窗: Over up to 18 months of follow-up.
Assessment of incidence of any plantarr ulcer recurrence.
Change in walking behavior (step timing)
时间窗: Assessed initially and every 6 months for 1 week for up to 18 months.
Actual assessment of change in walking behavior will be assessed by the timing of steps (how many steps in a given timeframe).
Change in walking behavior (steps)
时间窗: Assessed initially and every 6 months for 1 week for up to 18 months.
Actual assessment of change in walking behavior will be assessed by number of steps.
次要结局
- Bio-thesiometer(Assessed initially and every 6 months for up to 18 months)
- Exercise component of Summary of Diabetes Self-Care Activities Scale(Assessed initially and every 6 months for up to 18 months)
- Body Mass Index (BMI) and disease risk(Assessed initially and every 6 months for up to 18 months)
- Waist circumference(Assessed initially and every 6 months for up to 18 months)
研究者
Deborah M. Wendland, Ph.D.
Associate Professor
Mercer University