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Evaluation of Lower Extremity Tissue Perfusion With Polarized Laser Light

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03046628
Enrollment
30
Registered
2017-02-08
Start date
2017-02-28
Completion date
2018-06-30
Last updated
2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Ulcer, Perfusion

Brief summary

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

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.

Interventions

DEVICEGreen laser (at 532nm) and a fast camera
DEVICETcPO2

Sponsors

Bar-Ilan University, Israel
CollaboratorOTHER
Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between TcPO2 results and reflected secondary speckle patternsthrough study completion, an average of 1 yearrecording and comparing between the examinations of each diabetic ulcer

Contacts

Primary ContactOmer Slevin, M.D.
omerslevin@gmail.com0545563036

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026