Clinical Validation of a 'Hand-held' Fluorescence Digital Imaging Device for Wound Care Applications
Clinical Validation Study of a 'Hand-held' Point-of-Care Fluorescence Digital Imaging Device for Real-time Detection and Diagnosis of Wound Infections and Longitudinal Monitoring of Wound Healing Status
1 other identifier
observational
75
1 country
1
Brief Summary
The primary objective of this clinical study is to evaluate the use and effectiveness of our 'handheld' fluorescence digital imaging device platform for real-time non-invasive clinical monitoring of chronic wounds for healing and bacterial contamination/infectious status over time. This will enable us to determine if the device can detect and longitudinally track intrinsic changes that may occur during the wound healing process including, but not limited to, collagen re-modeling and bacterial infection of the wound site.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 20, 2011
CompletedFirst Posted
Study publicly available on registry
June 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedMay 19, 2017
May 1, 2017
8.2 years
June 20, 2011
May 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
wound size, bacterial load
3 weeks after imaging with device
Study Arms (1)
Patients with chronic or acute wounds.
Patients with chronic or acute wounds.
Eligibility Criteria
All patients previously diagnosed with chronic and/or acute wounds will be considered for eligibility into this study.
You may qualify if:
- Patients will be included in the study according to the following criteria:
- \> 18 years of age
- males and females
- presenting with chronic wounds (i.e., diabetic ulcers, etc.), with known or unknown infection status.
You may not qualify if:
- Patients will be excluded in the study according to the following criteria:
- treatment with an investigational drug within 1 month before study enrolment
- any contra-indication to routine wound care and/or monitoring
- patients with pre-existing skin issues (e.g. melanomas, psoriasis) in areas close to wound(s) that will be studied
- inability to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Health Network
Toronto, Ontario, M5G 2M9, Canada
Related Publications (1)
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.
PMID: 25790480DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph S DaCosta, PhD
Ontario Cancer Institute, University Health Network
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2011
First Posted
June 22, 2011
Study Start
February 1, 2009
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
May 19, 2017
Record last verified: 2017-05