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Clinical Validation of a 'Hand-held' Fluorescence Digital Imaging Device for Wound Care Applications

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ClinicalTrials.gov Identifier: NCT01378728
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : May 19, 2017
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : February 2009
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Patients with chronic or acute wounds.
Patients with chronic or acute wounds.

Primary Outcome Measures :
  1. wound size, bacterial load [ Time Frame: 3 weeks after imaging with device ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients previously diagnosed with chronic and/or acute wounds will be considered for eligibility into this study.

Inclusion Criteria:

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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378728

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Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Ralph S DaCosta, PhD Ontario Cancer Institute, University Health Network
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01378728    
Other Study ID Numbers: PRODIGI Wound Imaging Trial
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Keywords provided by University Health Network, Toronto:
Optical imaging
Fluorescence imaging
Chronic and acute wounds
Wound bacteria
Bacterial biofilms
Pathogenic bacteria
Wound infection
Wound healing
Treatment response assessment
Additional relevant MeSH terms:
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Wound Infection
Wounds and Injuries