Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers

NCT ID: NCT02202668

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2014-11-30

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.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

TRS

Group Type: EXPERIMENTAL

TRS

Intervention Type: DEVICE

TRS measurements of subcutaneous deep wound soft tissue and underlying bone will be collected at the same standard locations that are used to measure wound dimensions. The probe will never be in contact with the wound, but we will sterilize the probe head in advance in order to ease potential concerns regarding equipment sterility. A single point TRS measurement can be obtained in less than 60 seconds. At a minimum we will collect measurements at the geometric center of the wound as well as at the "6 and 12" and "3 and 9" ulcer coordinates. These coordinates are commonly used to estimate ulcer dimensions. It is anticipated that the PhAT probe will be used with a beam diameter of 7.5 mm. It is possible that the incident laser beam diameter will need to be adjusted (7.5 mm to 6.0 mm) to accommodate smaller wounds. If incident laser beam diameter adjustment is necessary we will also adjust the laser intensity to maintain the maximum permissible exposure of 0.3 W/cm2 per ANSI guidelines.

Interventions

TRS

TRS measurements of subcutaneous deep wound soft tissue and underlying bone will be collected at the same standard locations that are used to measure wound dimensions. The probe will never be in contact with the wound, but we will sterilize the probe head in advance in order to ease potential concerns regarding equipment sterility. A single point TRS measurement can be obtained in less than 60 seconds. At a minimum we will collect measurements at the geometric center of the wound as well as at the "6 and 12" and "3 and 9" ulcer coordinates. These coordinates are commonly used to estimate ulcer dimensions. It is anticipated that the PhAT probe will be used with a beam diameter of 7.5 mm. It is possible that the incident laser beam diameter will need to be adjusted (7.5 mm to 6.0 mm) to accommodate smaller wounds. If incident laser beam diameter adjustment is necessary we will also adjust the laser intensity to maintain the maximum permissible exposure of 0.3 W/cm2 per ANSI guidelines.

Intervention Type: DEVICE

Eligibility Criteria

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))

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Blake Roessler

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Blake Roessler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00083401

Identifier Type: -

Identifier Source: org_study_id