CompletedNot Applicable

MolecuLightDX Measurement Feature Clinical Validation

Canada34 participantsStarted 2024-10-23

Plain-language summary

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

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean and SD of percent error for wound area by the MLI device in manual and automatic modes and by ruler

Timeframe: up to 6 months

Trial details

NCT IDNCT06682923

SponsorMolecuLight Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-02-20

View on ClinicalTrials.gov More Wounds trials

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.