Clinical Trial: Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Transcutaneous Raman Spectroscope Analyses of Diabetic Foot Ulcers
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 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.
Detailed Summary:
Sponsor: University of Michigan
Current Primary Outcome: Transcutaneous Raman spectra of subcutaneous deep wound soft tissue and underlying bone [ Time Frame: Baseline, then monthly for 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Wound temperature post-Transcutaneous Raman Spectroscope [ Time Frame: Baseline then monthly for 3 months ]
Original Secondary Outcome: Same as current
Information By: University of Michigan
Dates:
Date Received: July 24, 2014
Date Started: September 2014
Date Completion:
Last Updated: April 17, 2017
Last Verified: April 2017