NCT03091361

Brief Summary

This is a non-randomized, single-blind post market clinical follow-up study for which 50 patients will be imaged at the Judy Dan Research and Treatment Centre who present with a chronic and are receiving standard wound care treatment. The i:X imaging device visualizes fluorescing bacteria in real-time. The device will be used as an adjunctive tool in the assessment of the wound and will be used to guide the targeted sampling of a wound (with curettage scraping). The overall objective of this work is to evaluate the positive predictive value (PPV) of the MolecuLight i:X Imaging Device in predicting the presence of bacteria in chronic wounds. The presence of bacteria will be determined micro-biologically by semi-quantitative culture analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

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

Study Start

First participant enrolled

June 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

January 18, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

November 8, 2016

Results QC Date

December 2, 2019

Last Update Submit

January 6, 2020

Conditions

Wounds and Injuries

Keywords

Bacterial imagingPPVChronic wounds

Outcome Measures

Primary Outcomes (1)

  • Positive Predictive Value (PPV) of Localized Red Fluorescence Signals With Microbiological Samples

    PPV reflects the probability that a region of red fluorescence within or around a wound will contain bacteria. Meaning the number cases where qPCR analysis of wound tissue biopsies from red fluorescent region showed to have pathogen load ≥ 104 CFU/g divided by the total number of cases where red florescence was observed in the wound multiplied by 100,

    3 months

Study Arms (1)

All patients (imaging/no intervention)

There is only one group in this study, the imaging/no intervention group. These patients will meet all enrollment criteria and bacterial (red or cyan) fluorescence will be visualized within or around their wound with the MolecuLight i:X imaging device. A targeted curettage sample will be taken from the site of fluorescence and sent for microbiological analysis. There will be no intervention or followup.

Other: imaging, no intervention

Interventions

imaging, no interventionOTHER

no intervention

All patients (imaging/no intervention)

Eligibility Criteria

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

Patients receiving routine wound care.

You may qualify if:

  • presents with a chronic wound of the lower limb (e.g. diabetic foot ulcer, venous leg ulcer, other acceptable aetiology)
  • red or cyan fluorescence signals observed within or around wound on MolecuLight i:X images

You may not qualify if:

  • Treatment with an investigational drug within 1 month before study enrollment
  • Use of systemic (oral or intravenous) antibiotics
  • Inability to consent to medical photography
  • Any contra-indication to routine wound care and/or monitoring

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

Related Publications (1)

  • Rennie MY, Lindvere-Teene L, Tapang K, Linden R. Point-of-care fluorescence imaging predicts the presence of pathogenic bacteria in wounds: a clinical study. J Wound Care. 2017 Aug 2;26(8):452-460. doi: 10.12968/jowc.2017.26.8.452.

    PMID: 28795890DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Results Point of Contact

Title
Liis Teene
Organization
MolecuLight Inc.
lteene@moleculight.com
416.542.5530

Study Officials

  • Ron Linden, MD

    Judy Dan Research and Treatment Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

November 8, 2016

First Posted

March 27, 2017

Study Start

June 1, 2016

Primary Completion

November 1, 2016

Study Completion

February 1, 2017

Last Updated

January 18, 2020

Results First Posted

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)