Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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 criteria
- 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))
Trial design
Primary purpose
Allocation
Interventional model
Masking
5 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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