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

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 Overview

• Status: Completed
• Conditions: Foot Ulcer, Diabetic; Bacteria
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M2R1N5
      • Judy Dan Research and Treatment Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who present with a diabetic foot ulcer and are receiving standard wound care treatment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of localized fluorescence signals in acquired images with microbiological samples	Microbiological swabs will be taking from fluorescence positive regions to correlate with bacterial presence	At study visit (only one study visit)
Comparison of number/variety of bacteria obtained by fluorescence-guided sampling vs. standard practice	Microbiological swabs will be taking from the wound using standard practice and following fluorescence-image guidance	At study visit (only one study visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the clinical functionality of the K2 Imaging Device	Users feedback	At study visit (only one study visit)

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: December 9, 2014
• First Posted (Estimate): December 11, 2014

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Diabetic Foot Ulcers; Bacteria; Fluorescence
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: 14-8303