Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers

Not Applicable

Terminated

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: TRS

• Registration Number: NCT02202668
• Lead Sponsor: University of Michigan

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 Description

Not available

Study Timeline

• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-29
• Study Start: 2014-09
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

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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))

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TRS	TRS	-

Primary Outcome Measures

Name	Time	Method
Transcutaneous Raman spectra of subcutaneous deep wound soft tissue and underlying bone	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.

Secondary Outcome Measures

Name	Time	Method
Wound temperature post-Transcutaneous Raman Spectroscope	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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States