A Prospective Multicenter Study Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of Recurrence
研究概览
简要总结
Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning.
详细描述
This study is a follow-up durability trial from the CAMPX randomized controlled clinical trial. Only subjects who achieved complete closure at 12 weeks in the CAMPX trial will be evaluated. After signing the IRB-approved informed consent form, the subject will receive instruction on the BlueDrop® OneStep Foot Scanner™. In addition, written instructions on use will be provided. Subjects that are unable to use the scale will be asked to answer a questionnaire at 3, 6, 9, and 12 months after signing the consent form..
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
- •The potential subject must have participated in the CAMPX trial and achieved complete closure by the 12-week endpoint.
排除标准
- •The potential subject did not participate in the CAMPX trial.
- •The potential subject participated in the CAMPX trial and did not achieve complete closure.
研究组 & 干预措施
OneStep Foot Scanner
This study is a follow-up durability trial from the CAMPX randomized controlled clinical trial. Only subjects who achieved complete closure at 12 weeks in the CAMPX trial will be evaluated. After signing the IRB-approved informed consent form, the subject will receive instruction on the BlueDrop® OneStep Foot Scanner™. In addition, written instructions on use will be provided. Subjects that are unable to use the scale will be asked to answer a questionnaire at 3, 6, 9, and 12 months after signing the consent form.
干预措施: Blue Drop Foot Scanner (Other)
结局指标
主要结局
Rate of Recurrence
时间窗: 52 weeks
To demonstrate durability of closure (rate of recurrence) of subjects with a closed diabetic foot ulcer during the CAMPX clinical trial comparing subjects treated with Single Layer Amniotic Membrane (SLAM) plus standard of care (SOC) to subjects treated with SOC alone.
次要结局
- Virtual Long-Term Follow Up(52 weeks)