NCT01651845|Unknown
Evaluation of a 'Hand-held' Fluorescence Digital Imaging Device for Real-Time Advanced Wound Care Monitoring (JDRTC/UHN)
JDRTC/UHN
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JDRTC/UHN
Sponsor study identifier
observational
80
1 country
1
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2017
Actual (reported)Study Completion
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
We have developed an innovative optical molecular imaging platform (called PRODIGI) based on high-resolution fluorescence and white-light technologies in a hand-held, real-time, high-resolution, non-invasive format. PRODIGI offers a non-contact means of obtaining instantaneous image-based measurements of diagnostically-relevant biological and molecular information of a wound and surrounding skin tissues for the first time and could have significant impact on improving conventional wound care, management, and guidance of intervention. The investigators hypothesize that real-time imaging of tissue autofluorescence signals emanating from endogenous connective tissue (e.g. collagen) and pathogenic bacteria within complex wounds can be used to determine healing status (i.e., collagen re-modeling and wound closure), detect wound bacterial contamination and/or infection that is occult under standard clinical white light evaluation, and guide intervention during wound care.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
July 25, 2012
Actual (reported)July 27, 2012
Actual (reported)September 2017
Actual (reported)September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Evaluate effectiveness of the UHN handheld PRODIGI™ imaging device for real-time and non-invasive detection and tracking of pathogenic bacterial presence, contamination and infectious status in complex wounds over time.
After study completion
Standard of care white light visual wound assessment followed by fluorescence image-guided wound assessment
The study will be conducted at the Judy Dan Research and Treatment Centre in Toronto. Patients of the JDRTC typically present with diabetic foot ulcers. Eighty new patients with wounds will be entered into this trial, based on statistical power-based calculations for sample size determined in collaboration with the UHN Biostatistics Group (assuming one wound per patient).
University Health Network - Judy Dan Research and Treatment Centre
Toronto, Ontario, M2R 1N5, Canada
DaCosta RS, Kulbatski I, Lindvere-Teene L, Starr D, Blackmore K, Silver JI, Opoku J, Wu YC, Medeiros PJ, Xu W, Xu L, Wilson BC, Rosen C, Linden R. Point-of-care autofluorescence imaging for real-time sampling and treatment guidance of bioburden in chronic wounds: first-in-human results. PLoS One. 2015 Mar 19;10(3):e0116623. doi: 10.1371/journal.pone.0116623. eCollection 2015.
Ralph S DaCosta, PhD
University Health Network, Toronto
First Submitted
July 25, 2012
First Posted
July 27, 2012
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2017
The Effects of Meditation and Hyperbaric Oxygen Therapy on Chronic Wounds
Contact the study team to confirm eligibility.
Study Completion
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 14, 2018
Record last verified: 2018-02
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