Point-spectroscopy Trial

• Conditions: Wound; Wound of Skin

• Registration Number: NCT05183698
• Lead Sponsor: MolecuLight Inc.

Brief Summary

Evaluation and characterization of autofluorescence signals of tissue in and around wounds as identified by MolecuLight fluorescence image.

Detailed Description

Evaluate and characterize autofluorescence signals of tissue components in and around wounds identified by MolecuLight FL images using a point spectrometer. The fluorescence spectroscopy data will yield quantitative spectral information, including the relative intensity and emission peak of the biological autofluorescence signatures.

Study Timeline

• Study First Submitted: 2021-12-07
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-04
• Last Update Submitted: 2022-01-04
• Study Start: 2022-01-10
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11
• Primary Completion: 2022-05-10
• Study Completion: 2022-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients presenting with acute or chronic wounds
• 18 years or older
• Willing to consent

Exclusion Criteria

• Treatment with an investigational drug within 1 month of enrolment
• Any contra-indication to regular wound care
• Inability or unwillingness to consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spectra of autofluorescent signatures of tissue in and around the wounds	2 months	Spectral characterization (i.e. emission curve including intensity) of the autofluorescence signal from wound tissue and surrounding tissue will be catalogued from all 50 study participants.