Tran-epidermal Water Loss (TEWL) as a Predictive Marker for Diabetic Foot Ulcer (DFU) Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 418
- 试验地点
- 6
- 主要终点
- Proportion of participants who have DFU wound recurrence by 16 weeks after complete wound healing
研究概览
简要总结
This is a multicenter study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict DFU wound recurrence. Trans-epidermal water loss (TEWL) will be measured on the closed wound site and a location similar to the wound site (reference site). Participants will be enrolled within two weeks after closure of their DFU. Complete wound healing will be verified at a second visit two weeks later and this visit will start the 16 week timeline where participants will be followed weekly by phone until the earliest of DFU wound recurrence or 16 weeks. Participants who experience a DFU wound recurrence and a subset of participants who do not experience a DFU wound recurrence by week 16 will be asked to attend one final visit.
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
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria at Visit 1:
- •Age > 18 years.
- •Willing and able to comply with protocol instructions.
- •Clinically diagnosed DFU is closed.
- •Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria.
- •Provides written informed consent.
- •At Visit 2, confirmation of complete wound healing, the following additional inclusion criterion must be met:
- •Confirmation that the target DFU that was assessed as healed at Visit 1 remains healed two weeks later (at Visit 2).
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •DFU wounds closed more than 2 weeks before Visit 1, or to be closed by flap or graft coverage
- •Closed DFU site whose size or location would not allow five separate TEWL measurements
结局指标
主要结局
Proportion of participants who have DFU wound recurrence by 16 weeks after complete wound healing
时间窗: 1 up to 16 weeks after wound closure
次要结局
- Clinician assessment of DFU wound recurrence(16 weeks)
- Participant self-report of DFU wound recurrence(16 weeks)
- Time to DFU wound recurrence after complete wound healing(Up to 16 weeks after wound closure)
研究者
Cathie Spino, ScD
Research Professor of Biostatistics, SABER Director
University of Michigan