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临床试验/NCT04054804
NCT04054804已完成不适用

Digital Foot Check by Using the D-Foot, a New Software

Sahlgrenska University Hospital, Sweden1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
The questionnaire Orthotic and Prosthetic Users Survey (OPUS) will be used.

研究概览

简要总结

Patients with diabetes should be thoroughly examined before they are provided with insoles and shoes. In the study the feet are examined with the help of a new software, the D-Foot. D-Foot includes questions and surveys.

The aim of the of the study is evaluate how the patients experience the visit at the department of Prosthetics & Orthotics based on the digital foot check.

详细描述

Patients with diabetes should be thoroughly examined before they are provided with insoles and shoes. The purpose of the foot examination is to determine whether the patient is at risk of developing diabetic foot ulcers (DFU). Risk factors are: neuropathy, peripheral angiopathy, foot deformities, skin pathologies, earlier history of DFU/amputation. With effective control and examination of the feet, foot complications, such as DFU, can be prevented. In the study the feet are examined with the help of a new software, the D-Foot. D-Foot includes questions and surveys.

The aim of the of the study is evaluate how the patients experience the visit at the department of Prosthetics & Orthotics based on the digital foot check.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The questionnaire Orthotic and Prosthetic Users Survey (OPUS) will be used.

时间窗: 2019-2020

Participants satisfaction with devices and services at the Department of Prosthetics and Orthotics will be evaluated.

次要结局

  • Presence of foot ulcers (number)(2019-2020)
  • Presence of peripheral angiopathy (percentage )(2019-2020)
  • Presence of foot ulcers (percentage)(2019-2020)
  • Presence of previous foot ulcers (percentage)(2019-2020)
  • Presence of neuropathy (number)(2019-2020)
  • Presence of calluses (percentage)(2019-2020)
  • System Usability Scale (SUS). The score range from 0-100 and a SUS score above a 68 would be considered above average and anything below 68 is below average.(2019-2020)
  • Presence of peripheral angiopathy (number )(2019-2020)
  • Presence of foot deformities (percentage)(2019-2020)
  • Presence of neuropathy (percentage)(2019-2020)
  • Presence of calluses (number)(2019-2020)
  • Presence of foot deformities (number)(2019-2020)
  • Presence of previous foot ulcers (number)(2019-2020)
  • Presence of previous amputation in the lower extremities (number)(2019-2020)
  • Presence of previous amputation in the lower extremities (percentage)(2019-2020)

研究者

发起方
Sahlgrenska University Hospital, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ulla Hellstrand Tang

Principal Investigator

Sahlgrenska University Hospital, Sweden

研究点 (1)

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