Recruiting

Observational Study

Sponsor:

MolecuLight Inc.

Code:

NCT03290690

Conditions

Wound

Chronic Leg Ulcer

Wound Contamination

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a non-randomized, single-blind post market clinical follow-up study for which 65 patients will be imaged at Rouge Valley Centenary Hospital (Scarborough and Rouge Hospital) who present with a chronic wound and are receiving standard wound care treatment. The MolecuLight i:X imaging device will be used by the study clinician 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), as per current standard of care in the principal investigator's wound care clinic. The acquired tissue sample will then be analysed using conventional gold standard semi-quantitative culture methods to determine bacterial species present, also as per current standard of care in this clinic.

Conditions

Wound

Chronic Leg Ulcer

Wound Contamination

Study ID

NCT03290690

Start date

Aug 4, 2017

Status verified date

Mar, 2020

Completion date

Jul 30, 2020

Anticipated

Primary completion date

Jul 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female patients presenting with a chronic wound (wound duration > 4 weeks) e.g. diabetic foot ulcer, venous leg ulcer, pressure ulcer, or other acceptable aetiology
2. 18 years or older

Exclusion Criteria:

1. Treatment with an investigational drug within 1 month before study enrolment
2. Inability to consent to medical photography (i.e. inability to understand consent process)
3. Any contra-indication to routine wound care and/or monitoring
4. Prior participation of the patient in this study (for the same wound or a different wound).

Study Design

Enrollment

65 participants

Anticipated

Interventions and Outcome Measures

Arms

All Subjects

All subjects in this study will have their wounds imaged and assessed in the following manner:

Capture and save ST-image Capture and save FL-image Identify discrete locations of cyan (blue/green) fluorescent bacteria (FL_C) Acquire sample of tissue where cyan fluorescent bacteria are present (using curette method) Consent patient for inclusion in this study Note location of sample acquisition by annotating FL-image obtained in step 2 Send sample for microbiology analysis Note naming of microbiology sample on Case Report Form

Primary outcome measure

  • Evaluate the ability of the MolecuLight i:X Imaging Device to predicting the presence of Pseudomonas aeruginosa in chronic wounds [ Time Frame: 1 hour ]

Central Contacts and Locations

Central contacts

Liis Teene

6472551519lteene@moleculight.com

Rose Raizman

416-886-2328rraizman@rougevalley.ca

Locations

Scarborough and Rouge Hospital

Recruiting

Scarborough, Ontario, Canada, M1E 4B9

Contacts

Rose Raizman, RN-EC

416-886-2328rraizman@rougevalley.ca

More Information

Sponsor

MolecuLight Inc.

Last update posted

Mar 6, 2020

Last verified

Mar, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MolecuLight Inc. on 2020-03-06.