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

NCT01651845 | Unknown

• 1 other identifier: 12-5003-A
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wounds; Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Image Guided Intervention

Standard of care white light visual wound assessment followed by fluorescence image-guided wound assessment

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

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).

You may qualify if:

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

You may not qualify if:

• treatment with an investigational drug within 1 month before study enrolment
• any contra-indication to routine wound care and/or monitoring
• inability to consent

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Cancer Care Ontario: collaborator

Study Sites (1)

University Health Network - Judy Dan Research and Treatment Centre

Toronto, Ontario, M2R 1N5, Canada

Location

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: 25790480 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Diabetic Foot

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

Study Officials

• Ralph S DaCosta, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: July 27, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2018
• Last Updated: February 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)