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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

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.

Condition or disease Intervention/treatment
Foot Ulcer, Diabetic Bacteria Device: Fluorescence Imaging

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.


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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Fluorescence-image Guided Wound Assessment vs. Standard Practice
Study Start Date : December 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Diabetic foot ulcers
Patients who present with diabetic foot ulcers will undergo fluorescence imaging.
Device: Fluorescence Imaging
Wounds will be imaged using violet light (405 nm) illumination to locate areas with bacterial presence to guide swabbing.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Assessment of the clinical functionality of the K2 Imaging Device [ Time Frame: At study visit (only one study visit) ]
    Users feedback


Biospecimen Retention:   Samples Without DNA
Microbiological samples (skin and wound swabs)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who present with a diabetic foot ulcer and are receiving standard wound care treatment.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315092


Locations
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Canada, Ontario
Judy Dan Research and Treatment Centre
Toronto, Ontario, Canada, M2R1N5
Sponsors and Collaborators
University Health Network, Toronto
Judy Dan Research and Treatment Centre
Investigators
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Principal Investigator: Ralph S DaCosta, PhD Princess Margaret Cancer Centre, University Health Network

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Responsible Party: Ralph DaCosta, Scientist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02315092     History of Changes
Other Study ID Numbers: 14-8303
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

Keywords provided by Ralph DaCosta, University Health Network, Toronto:
Diabetic Foot Ulcers
Bacteria
Fluorescence

Additional relevant MeSH terms:
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Foot Ulcer
Diabetic Foot
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies