Evaluation of the MolecuLightDX device for measuring surface wounds
Evaluation of the MolecuLightDX Device in the Measurement of Surface Wounds in Patients
This study is testing a new device called MolecuLightDX to see if it can measure surface wounds more accurately than using a regular ruler for patients with certain types of ulcers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 72 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | MolecuLight Inc. Industry-sponsored |
| Locations | 2 sites (Hamilton, Ontario and 1 other locations) |
| Trial ID | NCT06682923 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the accuracy of the MolecuLightDX device in measuring surface wounds compared to traditional ruler measurements. It involves a single-arm, paired clinical evaluation where wound measurements (area, length, and width) obtained from the device are compared to a reference standard established by an expert panel. The study focuses on patients with specific types of ulcers, ensuring that the wounds measured have well-defined borders and meet certain size criteria.
Who should consider this trial
Good fit: Ideal candidates include adults over 22 years old with diabetic foot ulcers, venous, arterial, or pressure ulcers that have well-defined borders and are larger than 0.5 cm².
Not a fit: Patients with circumferential wounds, poorly defined borders, or wounds located in hard-to-measure areas may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of wound measurements, leading to better treatment outcomes for patients with various types of ulcers.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving wound measurement accuracy, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hamilton, Ontario and 1 other locations
- The Mayer Institute — Hamilton, Ontario, Canada (Recruiting)
- SHN Research Institute — Scarborough Village, Ontario, Canada (Not_yet_recruiting)
Study contacts
- Study coordinator: Laura Jones-Donaldson, PhD
- Email: ljones@moleculight.com
- Phone: 416-542-5507
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.