MolecuLight All-in-One Oxygenation Clinical Utility

June 9, 2026 updated by: MolecuLight Inc.

A Prospective, Clinical Evaluation of the MolecuLightDX+ With OxySight Module to Observe the Clinical Utility of Tissue Oxygenation, Bacterial Fluorescence and Thermal Signatures

This is a prospective, clinical evaluation of the MolecuLightDX+ with OxySight Module in wound care.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Monroeville, Pennsylvania, United States, 15146
        • SerenaGroup Monroeville

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adults 18 years and older with surface wounds.

Description

Inclusion Criteria:

  • Male or female patients presenting with a wound
  • A wound is > 1 cm2 in area
  • 18+ years old
  • Willing to consent

Exclusion Criteria:

  • Contraindication to debridement
  • Undergoing radio- or chemotherapy
  • Wound located in a difficult to image location
  • Any condition deemed by the investigator to interfere with safety or data validity
  • 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
Tissue oxygenation informing fluorescence-guided debridement
Time Frame: up to 1 month
Evaluate the feasibility of using tissue oxygenation (StO2) to further inform fluorescence-guided debridement.
up to 1 month
Tissue oxygenation changes before and after debridement
Time Frame: up to 1 month
Observe and quantify changes in tissue oxygenation (StO2) from before to immediately after fluorescence-guided debridement.
up to 1 month

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 (Actual)

March 25, 2026

Primary Completion (Actual)

March 27, 2026

Study Completion (Estimated)

June 28, 2026

Study Registration Dates

First Submitted

June 9, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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