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Evaluation of Fluorescence-image Guided Wound Assessment vs. Standard Practice

NCT02315092 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2018-02-13

No results posted yet for this study

Summary

The current trial aims to compare the assessment of diabetic foot ulcers by fluorescence image guidance to standard practice. The device will be used to acquire fluorescence images of diabetic foot ulcers: when wounds are illuminated by violet/blue light, most pathogenic bacterial species emit a unique red fluorescence signal. The device is intended to be used as part of the clinical assessment process, which may include visual assessment, signs of heat or high temperature, the presence of exudate, and redness in the area. Images will guide the clinician to inspect, sample or further evaluate areas where fluorescing bacteria is present. This study will allow us to determine the benefit of fluorescence image-guided procedure as compared to standard clinical practice to assess bacterial burden in diabetic foot ulcers. Microbiological swabbing under standard practice and fluoresce-guided imaging will be performed in order to compare the two techniques.

Conditions

  • Foot Ulcer, Diabetic
  • Bacteria

Interventions

DEVICE

Fluorescence Imaging

Wounds will be imaged using violet light (405 nm) illumination to locate areas with bacterial presence to guide swabbing.

Sponsors & Collaborators

  • Judy Dan Research and Treatment Centre

    collaborator UNKNOWN

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Ralph S DaCosta, PhD · Princess Margaret Cancer Centre, University Health Network

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02315092 on ClinicalTrials.gov