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临床试验/NCT03341559
NCT03341559已完成不适用

Spatial Frequency Domain Imaging (SFD) for Assessment of Diabetic Foot Ulcer Development and Healing

University of Southern California1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
Perfusion in lower extremities

研究概览

简要总结

This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities for prediction of both healing and formation of diabetic foot ulcers.

The investigators will perform longitudinal imaging (for 12 months) in two cohorts of subjects

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

  • I. Will be followed up in clinic on monthly basis for the next 12 months per standard of care II. Belong to one of the two target groups
  • Subjects with an existing diabetic foot ulcer
  • Subjects determined "at risk" for an ulcer

排除标准

  • History of heart failure
  • Rheumatoid arthritis
  • Pregnant or lactating women

结局指标

主要结局

Perfusion in lower extremities

时间窗: 12-month

SFDI data outputs

次要结局

未报告次要终点

研究者

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

David Armstrong

Professor of Surgery and Director, Southwestern Academic Limb Salvage Alliance (SALSA)

University of Southern California

研究点 (1)

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