WoundNCT03540004
Evaluation of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds
An observational study of Wound, run by MolecuLight Inc. at 14 sites in United States.
Trial summary
This is a non-randomized evaluation for which 160 adult patients will be imaged at outpatient wound care clinics who present with a wound of unknown infection diagnostic status and are receiving standard treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound
- What is being tested?
- MolecuLight i:X Imaging Device
- Type of treatment
- Medical device
- How many people
- 367 participants
- Where
- 14 sitesUnited States
- Study dates
- 23 May 2018to 30 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) (e.g. DFU, VLU, PU, SSI)
Who may be able to join
- Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) (e.g. DFU, VLU, PU, SSI)
- 18 years or older
Who cannot join
- Treatment with an investigational drug within 1 month before study enrolment
- Subjects with recent (<30 days) biopsy of target wound
- Subjects with wounds that cannot be completely imaged by study device due to anatomic location
- Inability to consent
- Any contra-indication to routine wound care and/or monitoring
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Saint Mary's Center for Wound Healing
Athens, Georgia, 30306
Foot and Ankle Center
Bryn Mawr, Pennsylvania, 19010
Cleveland Foot and Ankle Clinic
Cleveland, Ohio, 44103
El Campo Memorial Hospital
El Campo, Texas, 77437
Saint Vincent Health Center
Erie, Pennsylvania, 16544
The Foot and Ankle Wellness Center of Western Pennsylvania
Ford City, Pennsylvania, 16226
Texas Gulf Coast Medical Group
Houston, Texas, 77036
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, 16201
New Hope Podiatry Group
Los Angeles, California, 90063
The Wound Treatment Center at Opelousas General Health System
Opelousas, Louisiana, 70570
Royal Research Group
Pembroke Pines, Florida, 33027
Serena Group Research Institute
Pittsburgh, Pennsylvania, 15222
The Heal Clinic
Tulsa, Oklahoma, 74136
Martin Foot and Ankle
York, Pennsylvania, 17402
About this study
Official title: A Prospective, Single-blind, Multi-center Clinical Study Evaluating the Use of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds.
This is a non-randomized evaluation for which 160 adult patients will be imaged at outpatient wound care clinics who present with a wound of unknown infection diagnostic status and are receiving standard treatment. The MolecuLight i:X Imaging Device will be used as an adjunctive tool in the assessment of the wound and may be used to guide the targeted sampling of a wound (using a conventional punch biopsy method).
- Conditions
- Wound
- Being tested
- MolecuLight i:X Imaging Device
- 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.
MolecuLight i:X Imaging DeviceDevice
The i:X Imaging Device uses built-in light-emitting diodes (LEDs) emitting 405 nm violet excitation light to illuminate the wound during fluorescence imaging in (FL-Mode). The light excites biological components of the wound and surrounding tissues. Non-biological components may also fluoresce although their presence in wounds is less common, provided the wound has been cleaned following standard care protocols. The resulting wound fluorescence wavelengths emitted are typically between 420 - 700 nm in the visible wavelength spectrum. In FL-mode, a customized fluorescence emission filter, which is mechanically placed in front of the built in imaging sensor and allows real-time capture of wound, limits the visualization of fluorescence to wavelengths between 500-545 nm, which typically appears green in color, and 600-665 nm, which typically appears red in color.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of identifying wounds with moderate/heavy bacterial load as measured by sensitivity and specificity.
Superiority in sensitivity of clinical signs and symptoms (CSS) and fluorescence imaging using MolecuLight i:X (CSS + i:X) vs. CSS alone to identify wounds with moderate/heavy bacterial load
Non-Inferiority of specificity of CSS and fluorescence imaging using MolecuLight i:X (CSS + i:X) vs. CSS alone with region of indifference of 10% to identify wounds with moderate/heavy bacterial load
Measured: 1 year
Secondary outcomes (1)
Estimation of sensitivity and specificity of MolecuLight i:X alone
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start23 May 2018
- Primary completion9 Apr 2019
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for WoundStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- MolecuLight Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Responsible party
- Sponsor
- Investigators
- Tomas E Serena, MD, Principal investigator, Serena Group Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540004
- Sponsor's protocol ID
- 18-001
- Status last verified
- Mar 2020
- First submitted
- 16 May 2018
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Johnson J, Johnson AR Jr, Andersen CA, Kelso MR, Oropallo AR, Serena TE. Skin Pigmentation Impacts the Clinical Diagnosis of Wound Infection: Imaging of Bacterial Burden to Overcome Diagnostic Limitations. J Racial Ethn Health Disparities. 2024 Apr;11(2):1045-1055. doi: 10.1007/s40615-023-01584-8. Epub 2023 Apr 11.
PubMed 37039975Serena TE, Gould L, Ousey K, Kirsner RS. Reliance on Clinical Signs and Symptoms Assessment Leads to Misuse of Antimicrobials: Post hoc Analysis of 350 Chronic Wounds. Adv Wound Care (New Rochelle). 2022 Dec;11(12):639-649. doi: 10.1089/wound.2021.0146. Epub 2021 Dec 3.
PubMed 34714159
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-blind, Multi-center Clinical Study Evaluating the Use of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds.
- ClinicalTrials.gov ID
- NCT03540004
- Acronym / sponsor ID
- 18-001
- Conditions
- Wound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 367 participants (actual)
- Lead sponsor
- MolecuLight Inc.Industry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Study start
- 23 May 2018 (actual)
- Primary completion
- 9 Apr 2019 (actual)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 30 May 2018 (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 non-randomized evaluation for which 160 adult patients will be imaged at outpatient wound care clinics who present with a wound of unknown infection diagnostic status and are receiving standard treatment. The MolecuLight i:X Imaging Device will be used as an adjunctive tool in the assessment of the wound and may be used to guide the targeted sampling of a wound (using a conventional punch biopsy method).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) (e.g. DFU, VLU, PU, SSI)
Key inclusion criteria (2 listed)
- Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) (e.g. DFU, VLU, PU, SSI)
- 18 years or older
Key exclusion criteria (5 listed)
- Treatment with an investigational drug within 1 month before study enrolment
- Subjects with recent (<30 days) biopsy of target wound
- Subjects with wounds that cannot be completely imaged by study device due to anatomic location
- Inability to consent
- Any contra-indication to routine wound care and/or monitoring
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 |
|---|---|---|
| MolecuLight i:X Imaging DeviceThe i:X Imaging Device uses built-in light-emitting diodes (LEDs) emitting 405 nm violet excitation light to illuminate the wound during fluorescence imaging in (FL-Mode). The light excites biological components of the wound and surrounding tissues. Non-biological components may also fluoresce although their presence in wounds is less common, provided the wound has been cleaned following standard care protocols. The resulting wound fluorescence wavelengths emitted are typically between 420 - 700 nm in the visible wavelength spectrum. In FL-mode, a customized fluorescence emission filter, which is mechanically placed in front of the built in imaging sensor and allows real-time capture of wound, limits the visualization of fluorescence to wavelengths between 500-545 nm, which typically appears green in color, and 600-665 nm, which typically appears red in color. | Device | – |
Primary outcome
Diagnostic accuracy of identifying wounds with moderate/heavy bacterial load as measured by sensitivity and specificity.
Time frame: 1 year
Superiority in sensitivity of clinical signs and symptoms (CSS) and fluorescence imaging using MolecuLight i:X (CSS + i:X) vs. CSS alone to identify wounds with moderate/heavy bacterial load Non-Inferiority of specificity of CSS and fluorescence imaging using MolecuLight i:X (CSS + i:X) vs. CSS alone with region of indifference of 10% to identify wounds with moderate/heavy bacterial load
1 secondary outcome
Estimation of sensitivity and specificity of MolecuLight i:X alone
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Derived from this study: PubMed 37039975Johnson J, Johnson AR Jr, Andersen CA, Kelso MR, Oropallo AR, Serena TE. Skin Pigmentation Impacts the Clinical Diagnosis of Wound Infection: Imaging of Bacterial Burden to Overcome Diagnostic Limitations. J Racial Ethn Health Disparities. 2024 Apr;11(2):1045-1055. doi: 10.1007/s40615-023-01584-8. Epub 2023 Apr 11.
- Derived from this study: PubMed 34714159Serena TE, Gould L, Ousey K, Kirsner RS. Reliance on Clinical Signs and Symptoms Assessment Leads to Misuse of Antimicrobials: Post hoc Analysis of 350 Chronic Wounds. Adv Wound Care (New Rochelle). 2022 Dec;11(12):639-649. doi: 10.1089/wound.2021.0146. Epub 2021 Dec 3.
- Individual participant dataSharing planned: No
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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.
Tomas E Serena, MD principal investigator
Serena Group Research Institute
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound, run by MolecuLight Inc. at 14 sites 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 2 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: status not confirmed, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Results are not available in the source record.
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?
Diagnostic accuracy of identifying wounds with moderate/heavy bacterial load as measured by sensitivity and specificity. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03540004, which also lists 2 linked publications.
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 6 Mar 2020.