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

NCT02315092 | Completed

• 1 other identifier: 14-8303
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Ulcer, Diabetic; Bacteria

Keywords

Diabetic Foot Ulcers; Bacteria; Fluorescence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Assessment of the clinical functionality of the K2 Imaging Device

  At study visit (only one study visit)

Study Arms (1)

Diabetic foot ulcers

Patients who present with diabetic foot ulcers will undergo fluorescence imaging.

Device: Fluorescence Imaging

Interventions

Fluorescence Imaging DEVICE

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

Diabetic foot ulcers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Treatment with an investigational drug within 1 month before study enrolment
• Inability to consent
• Any contra-indication to routine wound care and/or monitoring

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Judy Dan Research and Treatment Centre: collaborator

Study Sites (1)

Judy Dan Research and Treatment Centre

Toronto, Ontario, M2R1N5, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Microbiological samples (skin and wound swabs)

MeSH Terms

Conditions

Diabetic Foot

Interventions

Optical Imaging

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Ralph S DaCosta, PhD

  Princess Margaret Cancer Centre, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 11, 2014
• Study Start: December 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 13, 2018

Record last verified: 2018-02

Locations

CA (1)