MolecuLightDX Measurement Feature Clinical Validation

NCT ID: NCT06682923

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-23

Study Completion Date

2025-02-28

Brief Summary

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This is a prospective, single-arm, paired clinical evaluation of the MolecuLightDX device in the measurement of surface wounds in patients.

Detailed Description

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The study compares the accuracy of wound measurements (area, length, and width) obtained using the ruler (standard of care) method and the MolecuLightDX device with a ground truth measurement (reference standard) derived from an expert panel.

Conditions

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Wounds Wound of Skin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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MolecuLight DX Imaging Device

The MolecuLight DX Imaging Device is a fluorescence imaging device intended to acquire images from wounds. This will not alter the participant's standard of care treatment.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Willing to consent
* Willing to comply with all study procedures and availability for the duration of the study
* Male or female, aged over 22 years old
* Presented with diabetic foot ulcers, venous, arterial and pressure ulcers
* Wound size is greater than 0.5 cm2
* The wound has well-defined wound borders

Exclusion Criteria

* Circumferential wound
* Wound without clearly defined wound borders
* Wound located in a difficult to reach/measure location
* Any contra-indication to routine wound care and/or monitoring
* Wounds with a length greater than 18.5cm or a width greater than 13.5cm.
* Tunneled or undermined wounds
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MolecuLight Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Mayer Institute

Hamilton, Ontario, Canada

Site Status RECRUITING

SHN Research Institute

Scarborough Village, Ontario, Canada

Site Status NOT_YET_RECRUITING

Countries

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Canada

Central Contacts

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Laura Jones-Donaldson, PhD

Role: CONTACT

416-542-5507 ext. 5507

Hanna Varonina, MSc, CCRP

Role: CONTACT

416-542-5531 ext. 5531

Facility Contacts

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Perry Mayer, MD, BSc, FFPMRCPS (Glasg)

Role: primary

905-523-1444

Rose Raizman, NP, N-EC, PHCNP, NSWOC, WOCC

Role: primary

416-281-7111

Other Identifiers

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24-002

Identifier Type: -

Identifier Source: org_study_id

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