NCT07646938

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
0mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Mar 2026Jun 2026

Study Start

First participant enrolled

March 25, 2026

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2026

Expected
Last Updated

June 15, 2026

Status Verified

November 1, 2025

Enrollment Period

2 days

First QC Date

June 9, 2026

Last Update Submit

June 9, 2026

Conditions

Wounds

Outcome Measures

Primary Outcomes (2)

  • Tissue oxygenation informing fluorescence-guided debridement

    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

    Observe and quantify changes in tissue oxygenation (StO2) from before to immediately after fluorescence-guided debridement.

    up to 1 month

Interventions

MolecuLightDX+ with OxySight ModuleDEVICE

MolecuLightDX+ with OxySight Module is an imaging device intended to acquire fluorescence, oxygenation, thermal, and measurement images of wounds.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults 18 years and older with surface wounds.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SerenaGroup Monroeville

Monroeville, Pennsylvania, 15146, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 15, 2026

Study Start

March 25, 2026

Primary Completion

March 27, 2026

Study Completion (Estimated)

June 28, 2026

Last Updated

June 15, 2026

Record last verified: 2025-11

Locations

US(1)