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

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ClinicalTrials.gov Identifier: NCT02315092
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
Judy Dan Research and Treatment Centre
Information provided by (Responsible Party):
Ralph DaCosta, University Health Network, Toronto

Tracking Information
First Submitted Date December 9, 2014
First Posted Date December 11, 2014
Last Update Posted Date February 13, 2018
Study Start Date December 2014
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 9, 2014)
  • Correlation of localized fluorescence signals in acquired images with microbiological samples [ Time Frame: At study visit (only one study visit) ]
    Microbiological swabs will be taking from fluorescence positive regions to correlate with bacterial presence
  • Comparison of number/variety of bacteria obtained by fluorescence-guided sampling vs. standard practice [ Time Frame: At study visit (only one study visit) ]
    Microbiological swabs will be taking from the wound using standard practice and following fluorescence-image guidance
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 9, 2014)
Assessment of the clinical functionality of the K2 Imaging Device [ Time Frame: At study visit (only one study visit) ]
Users feedback
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Fluorescence-image Guided Wound Assessment vs. Standard Practice
Official Title Evaluation of Fluorescence-image Guided Wound Assessment vs. Standard Practice
Brief 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.
Detailed Description

Chronic wounds and their associated care are a burden to patients and health care systems worldwide. Microbiological testing of wound samples is often used to identify and quantify bacterial species, the latter of which may be both an objective quantitative indicator of infection and a predictive correlate of healing. Microbiology reports contain useful information about microbial identities, antibiotic susceptibility, and semi-quantitative bacterial growth rates, but these data typically represent the bacterial load in the wound centre only, and often arrive 3-5 days later. There is an unmet clinical need to improve the microbiological sampling and treatment of wound infections. To address this need, we developed a handheld portable imaging device that obtains white light (WL) and fluorescence (FL) images (or video) of normal skin and wounds in high-resolution and in real-time, which can be used at the point-of-care. It was demonstrated in previous studies that the device1) provides image-guidance for tissue sampling, detecting clinically-significant levels of pathogenic bacteria and wound infection otherwise overlooked by conventional sampling and 2) provides image-guidance for wound treatment, accelerating wound closure compared with conventional therapies and quantitatively tracking long-term changes in bacterial bioburden and distribution in wounds.

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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Microbiological samples (skin and wound swabs)
Sampling Method Non-Probability Sample
Study Population Patients who present with a diabetic foot ulcer and are receiving standard wound care treatment.
Condition
  • Foot Ulcer, Diabetic
  • Bacteria
Intervention Device: Fluorescence Imaging
Wounds will be imaged using violet light (405 nm) illumination to locate areas with bacterial presence to guide swabbing.
Study Groups/Cohorts Diabetic foot ulcers
Patients who present with diabetic foot ulcers will undergo fluorescence imaging.
Intervention: Device: Fluorescence Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 12, 2018)
80
Original Estimated Enrollment
 (submitted: December 9, 2014)
30
Actual Study Completion Date January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or female who present with a diabetic foot ulcer and are receiving standard wound care treatment.
  • 18 years and older

Exclusion Criteria:

  • Treatment with an investigational drug within 1 month before study enrolment
  • Inability to consent
  • Any contra-indication to routine wound care and/or monitoring
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02315092
Other Study ID Numbers 14-8303
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ralph DaCosta, University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators Judy Dan Research and Treatment Centre
Investigators
Principal Investigator: Ralph S DaCosta, PhD Princess Margaret Cancer Centre, University Health Network
PRS Account University Health Network, Toronto
Verification Date February 2018