Status:
TERMINATED
Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers
Lead Sponsor:
University of Michigan
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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))
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT02202668
Start Date
September 1 2014
End Date
November 1 2014
Last Update
April 19 2017
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109