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临床试验/NCT03942081
NCT03942081招募中不适用

Testing the Accuracy and Feasibility of Diabetic Foot Ulcer Imaging

Linnea Polgreen2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年9月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
2
主要终点
Foot Ulcer Size

研究概览

简要总结

All study procedures will occur during one appointment. The research team will measure the size of the foot ulcer (if one is present) and multiple photos will be taken with a smart phone camera and thermal camera. Demographic information will be obtained from the medical record.

详细描述

The research procedures consist of a) a research assistant measuring the size of the foot ulcer (for ulcer patients), b) patients having pictures of their feet taken with a smart phone under 4 conditions- 1) photos taken by researchers, 2) photos taken by the patient by hand, 3) photos taken by the patient with a selfie stick, and 4) photos taken by a 3rd party (e.g., friend/family member of patient). If the patient is not able to take photographs under any of the conditions, that condition will be excluded. In addition to photos being taken with a smart phone, additional photos will be taken with a thermal camera by the research team to determine if there is a difference in ulcer size depending on type of camera used. It is anticipated that procedures will last between 15 and 45 minutes. There is no long-term follow-up. If a patient returns to the clinic they will be asked if they wish to complete all study procedures again. Once the patient has left the clinic, the research team will check the medical record for: age, sex, race, ethnicity, BMI, co-morbidities, and zip code (to determine if patient lives in an urban or rural location).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
21 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Type 1 or Type 2 Diabetes
  • Has a current foot lesion
  • Receiving care through University of Iowa Hospitals and Clinics (UIHC) Iowa River Landing Diabetes Clinic, UIHC Internal Medicine Clinic, or UIHC Orthopedic Clinic.

排除标准

  • Cognitive impairment that prevents consent
  • Lack of fluency in speaking or understanding English
  • Known aversion to research studies

研究组 & 干预措施

Ulcer Measurement and Photo Group

Experimental

Diabetic patients with foot ulcers being seen in clinic.

干预措施: Ulcer Measurement Software (Device)

Healthy Control Group

No Intervention

Patients without foot ulcers being seen in the clinic.

结局指标

主要结局

Foot Ulcer Size

时间窗: 45 minutes

Size of foot ulcers will be determined by measurement and estimated by software

次要结局

  • Quality of Photos: 1 - 5 scale(45 minutes)

研究者

发起方
Linnea Polgreen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Linnea Polgreen

Associate Professor, Department of Pharmacy Practice and Science / Division of Health Services Research

University of Iowa

研究点 (2)

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