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

Foot Ulcer, Diabetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02315092
• Other study ID #: 14-8303
• Status: Completed
• Phase: N/A
• First received: December 9, 2014
• Last updated: February 12, 2018
• Start date: December 2014
• Est. completion date: January 2017

Study information

• Verified date: February 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteria
• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic

Intervention

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

Locations

Country	Name	City	State
Canada	Judy Dan Research and Treatment Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Judy Dan Research and Treatment Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Assessment of the clinical functionality of the K2 Imaging Device	Users feedback	At study visit (only one study visit)