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临床试验/NCT05092620
NCT05092620终止不适用

Adjunct Collection of Additional Biorepository Data From Patients Enrolled in DFC Trials

University of Michigan5 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
142
试验地点
5
主要终点
Participants consenting

研究概览

简要总结

The Biorepository will guide the Diabetic Foot Consortium (DFC) activities for collection and storing biosamples and data from participants enrolled in other current and future DFC research studies.

详细描述

Participants enrolling in a parent DFC research study will be concurrently approached about participating in the DFC Biorepository as well. If agreeable, participants will be asked to provide blood, urine, wound debridement tissue and wound dressing samples at the time of enrollment and once more if appropriate and as coincides with the primary study visit schedule. Participants will also be contacted via phone for every six months for two years thereafter to gather longitudinal data about their wound. Data and samples from the Biorepository, along with data collected during the primary study will be available to ancillary researchers.

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

  • Provides written informed consent
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Age > 18 years
  • Previous diagnosis of Type 1 or Type 2 diabetes or pre-diabetes per American Diabetes Association (ADA) guidelines
  • Inclusion in a part of any planned or approved DFC protocol

排除标准

  • An individual who meets exclusion criteria of the primary DFC protocol in which they are enrolled will also be excluded from participation in the biorepository program as well.

结局指标

主要结局

Participants consenting

时间窗: Up to 2 years

Proportion of participants consenting to participation in the biorepository from among DFC studies, by study and overall

Biospecimens collected

时间窗: Up to 2 years

Proportion of biospecimens collected, by type, from among those expected, by study and overall

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

Cathie Spino, ScD

Research Professor of Biostatistics, SABER Director

University of Michigan

研究点 (5)

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