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临床试验/NCT04460573
NCT04460573招募中2 期

Improving the Science of Adherence Reinforcement and Safe Mobility in People With Diabetic Foot Ulcers Using Smart Offloading

University of Southern California4 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2021年10月19日最近更新:
适应症
干预措施

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

Active Comparator

Smart boot rendered irremovable with cohesive bandage; no feedback on adherence.

干预措施: Boot (Device)

Smart boot removable

Active Comparator

Smart boot, removable, without feedback on adherence.

干预措施: Boot (Device)

Smart boot removable+reinforcement

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Armstrong

Professor

University of Southern California

研究点 (4)

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