WoundsNCT07646938
MolecuLight All-in-One Oxygenation Clinical Utility
An observational study of Wounds, run by MolecuLight Inc. at 1 site in United States.
Trial summary
This is a prospective, clinical evaluation of the MolecuLightDX+ with OxySight Module in wound care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds
- What is being tested?
- MolecuLightDX+ with OxySight Module
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2026to 27 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adults 18 years and older with surface wounds.
Who may be able to join
- Male or female patients presenting with a wound
- A wound is > 1 cm2 in area
- 18+ years old
- Willing to consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
SerenaGroup Monroeville
Monroeville, Pennsylvania, 15146
About this study
Official title: 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.
- Conditions
- Wounds
- Being tested
- MolecuLightDX+ with OxySight Module
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MolecuLightDX+ with OxySight ModuleDevice
MolecuLightDX+ with OxySight Module is an imaging device intended to acquire fluorescence, oxygenation, thermal, and measurement images of wounds.
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue oxygenation informing fluorescence-guided debridement
Evaluate the feasibility of using tissue oxygenation (StO2) to further inform fluorescence-guided debridement.
Measured: up to 1 month
Tissue oxygenation changes before and after debridement
Observe and quantify changes in tissue oxygenation (StO2) from before to immediately after fluorescence-guided debridement.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start25 Mar 2026
- Primary completion27 Mar 2026
- Study completion27 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- MolecuLight Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646938
- Sponsor's protocol ID
- 25-004
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Clinical Evaluation of the MolecuLightDX+ With OxySight Module to Observe the Clinical Utility of Tissue Oxygenation, Bacterial Fluorescence and Thermal Signatures
- ClinicalTrials.gov ID
- NCT07646938
- Acronym / sponsor ID
- 25-004
- Conditions
- Wounds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- MolecuLight Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 27 Mar 2026 (actual)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, clinical evaluation of the MolecuLightDX+ with OxySight Module in wound care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults 18 years and older with surface wounds.
Key inclusion criteria (4 listed)
- Male or female patients presenting with a wound
- A wound is > 1 cm2 in area
- 18+ years old
- Willing to consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MolecuLightDX+ with OxySight ModuleMolecuLightDX+ with OxySight Module is an imaging device intended to acquire fluorescence, oxygenation, thermal, and measurement images of wounds. | Device | – |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
Related trials for Wounds
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
Recruiting
Management of Abdominal Post-surgical Scar With Ozoaqua Versus Standard Care
Wound Healing, Abdominal Surgery
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
RecruitingPhase 1
APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System
Wounds and Injuries
Not yet recruitingObservational study
Results of Medical and Nursing Record,Physical Examination, Blood Test and Radiological Examination of Multiple Trauma to Find the Correlation With Patient's Morality and Mobility
Trauma Centers/Statistics & Numerical Data, Trauma Blunt
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds, run by MolecuLight Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue oxygenation informing fluorescence-guided debridement (time frame: up to 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.