Evaluation of Lower Extremity Tissue Perfusion With Polarized Laser Light

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetic Ulcer, Perfusion

Intervention / Treatment
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* Device: TcPO2
* Device: Green laser (at 532nm) and a fast camera


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with diabetic feet ulcers<br>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<br> <br> * Other names: TCM400, Radiometer, Denmark;Device: Green laser (at 532nm) and a fast camera<br> <br> * Other names: PixelLink PL-E531, continuous green laser;|

What is the study measuring?
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Primary Outcome Measures

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