MolecuLightDX Measurement Feature Clinical Validation
Recruiting
- Conditions
- WoundsWound of Skin
- Registration Number
- NCT06682923
- Lead Sponsor
- MolecuLight Inc.
- Brief Summary
This is a prospective, single-arm, paired clinical evaluation of the MolecuLightDX device in the measurement of surface wounds in patients.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 72
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean and SD of percent error for wound area by the MLI device in manual and automatic modes and by ruler up to 6 months
- Secondary Outcome Measures
Name Time Method Mean and standard deviation of inter- and intra-user coefficient of variation (CV) for wound area measured by the MolecuLight device in manual and automaitc modes up to 6 months
Trial Locations
- Locations (2)
The Mayer Institute
🇨🇦Hamilton, Ontario, Canada
SHN Research Institute
🇨🇦Scarborough, Ontario, Canada