Transcutaneous Raman Spectroscope Analyses of Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Transcutaneous Raman spectra of subcutaneous deep wound soft tissue and underlying bone
研究概览
简要总结
The primary translational research objective of the study is to demonstrate feasibility of using the Transcutaneous Raman Spectroscopy technology in a point-of-care environment. This study represents an initial evaluation of the device in a small cohort of human patients with diabetic foot ulcers. We will be evaluating safety, device design and certain human engineering factors associated with point of care use of the TRS. We anticipate the data we collect in this study will form the basis of later medical device studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide informed consent
- •Diagnosis of diabetes mellitus
- •Full thickness or superficial foot and ankle ulcers based on clinical assessment (e.g., University of Texas (UT) grades 1-3, stages A-D). For reference, see Appendix 1 for the UT classification table
排除标准
- •Age less than 18 or greater than 80 years old
- •Subject has a psychological or sociological condition or an addictive disorder that would preclude informed consent
- •Completely epithelialized ulcer based on clinical assessment with no ischemia or infection (UT classification 0A)
- •Current or previous use of anti-resorptive bisphosphonate drugs (e.g., risedronate (Actonel) and alendronate (Fosamax))
结局指标
主要结局
Transcutaneous Raman spectra of subcutaneous deep wound soft tissue and underlying bone
时间窗: Baseline, then monthly for 3 months
We will equip our portable Raman instrument with a non contact probe (PhAT probe, Kaiser Optical Systems). The probe will be placed \~ 10 inches from the wound and it will not be in contact with the wound. Depending on the size of the wound, the laser spot size on the wound bed will be 6-7.5 mm. The Raman spectra are derived from the laser light reflected back into the probe and captured by a charge coupled device (CCD) in the spectroscope. Computer software algorithms are used to deconvolute the CCD information into an interpretable Raman spectrum.
次要结局
- Wound temperature post-Transcutaneous Raman Spectroscope(Baseline then monthly for 3 months)
研究者
Blake Roessler
Professor
University of Michigan