Evaluation of Lower Extremity Tissue Perfusion With Polarized Laser Light

February 5, 2017 updated by: Meir Medical Center

A Feasibility Study of Using Technology Based on Polarized Laser Light and Speed Camera for Non-invasive Tissue Perfusion Assessment of the Lower Extremities

The aim of this study is to test the feasibility of using polarised green laser and CMOS camera in order to assess the tissue perfusion of lower extremity ulcers in patients suffering from diabetic foot by comparing this method with the percutaneous tissue oxygen tension examination which is currently the "gold standard" examination.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

An objective assessment of blood supply and oxygen delivery to the damaged tissue in patients with diabetic ulcer is very problematic with various currently accepted auxiliary examinations. These tests include measuring blood pressure ratio between the ankle or toes arm (ABI \ TBI), Sonar Doppler examination of the lower limb arteries, and percutaneous tissue oxygen tension examination (TcPO2). Each of these tests, along with the obvious advantages esprit ability to assess a non-invasive blood as number of disadvantages.

As the blood supply to the tissue is the most important healing of the tissue regardless of the type of intervention chosen (conservative treatment includes systemic antibiotics or surgical debridement), there is clear necessity for a non-invasive test with high reliably assessing tissue perfusion in patients with diabetic ulcers.

Recently, a new a method for assessing multiple features in vital tissues using polarised laser light was introduced. The technique is based on tracking temporal changes of reflected secondary speckles produced in the skin when being illuminated by a laser beam. Change in skin's temporal vibration profile is generated by time varied oxygen concentration caused these temporal changes. This technology of nanometer motion sensing allows, according to studies already carried out, monitoring parameters such as blood pressure, pulse rate and heart rhythm, glucose concentration in the blood substances and alcohol, oxygen saturation and intraocular pressure.

In this study the investigators will examine, non-invasively, the tissue around the lower limb ulcers of 30 diabetic patients, beginning with the TcPO2 examination followed by the polarised laser light and complementary metal-oxide semiconductor (CMOS) camera examination, and analysing the data in order to determine the ability of the latter method for assessing the tissue oxygen pressure.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients suffering from chronic diabetic ulcers

Exclusion Criteria:

  • Patients after amputation of some part in the lower limb
  • Patients with acute infection on bony involvement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with diabetic feet ulcers
Each patient will be examined twice, first with TcPO2 (TCM400, Radiometer Medical ApS, Denmark) and then with a green laser (harmonic of continuous neodymium-doped yttrium aluminium garnet laser 532-nm wavelength and fast camera (PixelLink PLE531) system.
Device: TcPO2
Other Names:
  • TCM400, Radiometer, Denmark
Device: Green laser (at 532nm) and a fast camera
Other Names:
  • PixelLink PL-E531, continuous green laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between TcPO2 results and reflected secondary speckle patterns
Time Frame: through study completion, an average of 1 year
recording and comparing between the examinations of each diabetic ulcer
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Collaborators

Bar-Ilan University, Israel

Investigators

  • Study Director: Meir Nyska, Prof., Head of the orthopaedic department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2017

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

February 5, 2017

First Posted (Estimate)

February 8, 2017

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • MMC1602-16CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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