Improving the Science of Adherence Reinforcement and Safe Mobility in People With Diabetic Foot Ulcers Using Smart Offloading
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 4
- 主要终点
- Wound healing
研究概览
简要总结
The purpose of this study is to help people with diabetes who develop neuropathic diabetic foot ulcers (DFUs). These ulcers, or sores, if left untreated can increase the chance of amputation. Part of the treatment is to have the person wear a diabetic shoe or boot to help their foot heal. Sometimes people don't wear the boot like they are told. The investigators want to compare three different kinds of diabetic boots to see if they can help make it easier for people to wear their boots as instructed.
The investigators will look at three groups of participants: the first group will wear a boot that can't be taken off. The second group will wear a boot that can be taken off, and they will get counseling about how important it is to follow instructions as to how often and when to wear the boot. The third group will wear a "smart" boot, which will interact with the person through a smart watch and smart phone, and give them direct feedback about how they are doing with following their boot wearing prescription.
The investigators will also be looking at how much physical activity, like walking, the participants do. And they will compare how well participants sleep and rate their quality of life in the three different boots. The investigators think that giving participants information about how much they are wearing their boot using readily available technology will help them to follow the doctor's directions better, and help their wounds heal faster.
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
- Single (Outcomes Assessor)
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
- •Male or Female aged 18 or older
- •Diabetic Foot Ulcer requiring offloading
- •Able to provide written informed consent
排除标准
- •Wound present for more than one year
- •HbA1c > 12%
- •Ankle Brachial Index (ABI) of index limb is <0.9 and/or they are being considered for revascularization within the course of the study
- •Ulcer involving bone or tendon
- •Ulcer not caused by diabetes
- •Unable or unwilling to attend prescribed clinic visits
- •Fully confined to a wheelchair
研究组 & 干预措施
Smart boot irremovable
Smart boot rendered irremovable with cohesive bandage; no feedback on adherence.
干预措施: Boot (Device)
Smart boot removable
Smart boot, removable, without feedback on adherence.
干预措施: Boot (Device)
Smart boot removable+reinforcement
Smart boot with, removable, with reinforcement of adherence via smart watch and smart phone as well as remote patient monitoring.
干预措施: Boot (Device)
结局指标
主要结局
Wound healing
时间窗: 12 weeks
Percent healed
Adherence to offloading
时间窗: 12 weeks
Average daily hours of device wear during weight bearing activities, objectively measured using smart boot
次要结局
- Speed of wound healing(12 weeks)
- Physical Activity(12 weeks)
研究者
David Armstrong
Professor
University of Southern California
