Wound of Skin, Wounds
Conditions
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.
Interventions
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.
Sponsors
MolecuLight Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Outcome results
None listed