Body-worn Sensor Technology for Improving Diabetic Care During Activities of Daily Living
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Wound size
研究概览
简要总结
The aim of the study was to explore the association between activities of daily living ( measured using a body-worn sensor) on wound healing in diabetic patients. Since this was an exploratory study, there was no study hypothesis.
详细描述
Diabetes patients with active foot ulcers were recruited and monitored for activities of daily living while wearing an offloading device.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 37 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 or older with non-infected, non-ischemic foot ulcers
- •active neuropathic foot ulcer
排除标准
- •major foot amputation
- •active Charcot arthropathy
- •ankle brachial index of 0.5 or less
- •history of substance abuse within 6 months
- •inability to walk 20m
研究组 & 干预措施
Removable Cast Walker
An offloading device that can be removed by the patients
干预措施: Removable cast walker (Device)
Irremovable Cast Walker
A removable cast rendered irremovable using instant total contact cast, so patients cannot remove offloading device.
干预措施: Irremovable cast walker (Device)
结局指标
主要结局
Wound size
时间窗: 12 weeks
Wound size was measured every week for 12 weeks
Daily Physical Activities
时间窗: 12 weeks
Recorded using a body-worn sensor and measured every 4 weeks for 2 days.
次要结局
未报告次要终点