Adjunct Collection of Additional Biorepository Data From Patients Enrolled in DFC Trials
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
- 否
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
Cathie Spino, ScD
Research Professor of Biostatistics, SABER Director
University of Michigan
