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Evaluation of a 'Hand-held' Fluorescence Digital Imaging Device for Real-Time Advanced Wound Care Monitoring (JDRTC/UHN)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Cancer Care Ontario
Information provided by (Responsible Party):
Ralph DaCosta, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01651845
First received: July 25, 2012
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

The investigators have recently developed an innovative optical molecular imaging platform (called PRODIGI(TM)) based on high-resolution fluorescence and white-light technologies in a hand-held, real-time, high-resolution, non-invasive format. PRODIGI(TM) 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. In preliminary preclinical testing, the investigators have discovered that when wounds are illuminated by violet/blue light, endogenous collagen in the connective tissue matrix emit a characteristic green fluorescent signal, while most pathogenic bacterial species emit a unique red fluorescence signal due to the production of endogenous porphyrins. Therefore, with autofluorescence imaging, no exogenous contrast agents are needed during imaging, making this approach particularly appealing as a diagnostic imaging method for clinical use.

Based on extensive preclinical studies in our labs, PRODIGI(TM) has demonstrated its capability at collecting autofluorescence images of wounds and detecting the presence and relative changes in connective tissue (e.g. collagen) content and bio-distribution involved in wound healing. It can also detect the presence and relative amounts of commensal and pathogenic bacteria within the wound based on autofluorescence alone (these bacteria are invisible to standard visualization with the naked eye using white light), thus providing a measure of infection status. This could significantly impact clinical wound care and management by i) reducing the complications associated with missed detection of bacterial infection under conventional practice, ii) facilitating image-guided wound sampling by targeted swabbing/biopsy and iii) monitoring wound healing and treatment response over time.

Previous Related Studies: A pilot-level clinical study (UHN REB protocol # 09-0015-A, PI: DaCosta, 50 patients imaged to date) performed by our group from 2008-2011 to assess the clinical utility of the device successfully demonstrated that tissue autofluorescence produced by endogenous collagen/elastin in the skin appears green in the fluorescent images, while most clinically-relevant bacterial colonies present in the wound produce a red fluorescence signal caused by endogenous porphyrins. Some bacterial species (e.g. pseudomonas aeruginosa) produce a green fluorescence signal that can be differentiated spectrally and texturally from the fluorescence of the dermis (another hue of green, discernable by our proprietary image analysis software). The PRODIGI(TM) device is sensitive enough to detect these green and red fluorescence signals from tissue and bacteria confirming the utility of this compact and portable imaging platform for clinical wound care.

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.


Condition
Wounds
Diabetic Foot Ulcers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a 'Hand-held' Fluorescence Digital Imaging Device for Real-Time Advanced Wound Care Monitoring (JDRTC/UHN)

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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. [ Time Frame: After study completion ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Image Guided Intervention
Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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).

Criteria

Inclusion Criteria:

  1. > 18 years of age
  2. males and females
  3. new patient to the JDRTC to ensure consistent work-up procedures (as described below) prior to treatment
  4. presenting with acute or chronic wounds (i.e., diabetic ulcers or other), with known or unknown infection status.

Exclusion Criteria:

  1. treatment with an investigational drug within 1 month before study enrolment
  2. any contra-indication to routine wound care and/or monitoring
  3. inability to consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651845

Locations
Canada, Ontario
University Health Network - Judy Dan Research and Treatment Centre
Toronto, Ontario, Canada, M2R 1N5
Sponsors and Collaborators
University Health Network, Toronto
Cancer Care Ontario
Investigators
Principal Investigator: Ralph S DaCosta, PhD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Ralph DaCosta, Principal Investigator, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01651845     History of Changes
Other Study ID Numbers: 12-5003-A
Study First Received: July 25, 2012
Last Updated: October 8, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Diseases
Leg Ulcer
Skin Diseases
Skin Ulcer
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014