NCT03754426

Brief Summary

Patients with chronic wounds will be imaged using 3 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 3 imaging devices will be compared off-line by 5 interpreters to assess for any differences in the images that would alter a clinical decision.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

November 26, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2019

Completed
Last Updated

December 3, 2019

Status Verified

November 1, 2019

Enrollment Period

1 month

First QC Date

November 22, 2018

Last Update Submit

November 29, 2019

Conditions

Wound

Outcome Measures

Primary Outcomes (1)

  • Concordance

    Estimate concordance of moderate/heavy bacterial load present in images acquired with each of 3 devices

    2 months

Interventions

Fluorescence Imaging DeviceDEVICE

Hand-held, real-time fluorescence imaging device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with chronic wounds

You may qualify if:

  • Subjects (inpatient/outpatient) presenting with a wound
  • Wound size less than 15 cm in length
  • years or older

You may not qualify if:

  • Treatment with an investigational drug within 1 month before study enrolment
  • Subjects with recent (\<30 days) biopsy or curettage of target wound
  • Subjects with wounds that cannot be completely imaged by study device due to anatomic location
  • Unable or unwilling to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Judy Dan Research and Treatment Centre

North York, Ontario, M2R 1N5, Canada

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Ron Linden, MD

    Judy Dan Research and Treatment Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2018

First Posted

November 27, 2018

Study Start

November 26, 2018

Primary Completion

January 2, 2019

Study Completion

January 2, 2019

Last Updated

December 3, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

There is no plan to disseminate information to patients. If patients ask for their information then they will be provided a response with the most up to date information.

Locations

CA(1)