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 ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Wound temperature post-Transcutaneous Raman Spectroscope [ Time Frame: Baseline then monthly for 3 months ]

Local temperature measurements of the wound will be collected before and immediately after the Raman measurements using a commercially available non-contact infrared thermometer which is also used to measure temperature in pediatric patients


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