Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers
Stopped early · Not applicable
Conditions studied: Diabetic Foot Ulcer
In brief
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.
Key facts
- Study ID
- NCT02202668
- Run by
- University of Michigan
- People needed
- 5
- Starts
- 2014-09-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2017-04-19
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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))
Where it is running
- University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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