Point-spectroscopy Trial

January 4, 2022 updated by: MolecuLight Inc.

Spectroscopic Assessment of Autofluorescent Signatures of Tissue in and Around Wounds Identified by MolecuLight i:X Imaging Device

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

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic and/or acute wound

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spectra of autofluorescent signatures of tissue in and around the wounds
Time Frame: 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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MolecuLight Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 10, 2022

Primary Completion (ANTICIPATED)

May 10, 2022

Study Completion (ANTICIPATED)

December 10, 2022

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

January 4, 2022

First Posted (ACTUAL)

January 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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