Skin Burn MultipleNCT01166893
Ability of Modulated Imaging and Laser Speckle Imaging to Determine Burn Wound Severity and Healing Potential
An observational study of Skin Burn Multiple, run by University of California, Irvine at 1 site in United States.
Trial summary
According to the National Burn Repository 2007, the most common type of burn injury is a partial thickness burns. The current standard of care for partial thickness burns is two weeks of topical therapy and wound care. Burns that do not heal within two weeks undergo surgical excision and skin grafting. Read more about this study
- Who is it for?
- Ages 1 minute and older
- Conditions the study is for
- Skin Burn Multiple
- What is being tested?
- Modulated Imaging and Laser Speckle Imaging
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 minute and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population will be selected from University of California Irvine Medical Center Burn Unit.
Who may be able to join
- Male / female all age
- Subjects is an inpatient or out patient with burn wound
Who cannot join
- Subjects cannot lied flat and still for the duration of the imaging
- Subjects pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCIMC
Orange, California, 92868
Victor Joe, MD, 714-456-5840
About this study
According to the National Burn Repository 2007, the most common type of burn injury is a partial thickness burns. The current standard of care for partial thickness burns is two weeks of topical therapy and wound care. Burns that do not heal within two weeks undergo surgical excision and skin grafting.
Read the detailed description
Researcher can use the combination of Modulated Imaging and Laser Speckle Imaging can be used as an adjuvant to standard clinical evaluation to gauge burn wound and severity of infection. Researcher can image the burn wounds of and compare with current standard of care, clinical exam, and can use the outcomes information in terms of time to healing and treatment
Modulating Imaging is a noninvasive optical modality measure the metabolic functions of the burn wound.
Laser Speckle Imaging is a noninvasive optical modality can measure blood flow of burn wound.
- Conditions
- Skin Burn Multiple
- Being tested
- Modulated Imaging and Laser Speckle Imaging
- Keywords
- burn wound
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modulated Imaging and Laser Speckle ImagingDevice
Also called MI-LSI developed at UCI Beckman Laser Institute
wound healing
| Study group | Role | What they receive |
|---|---|---|
| Burn wound | Modulated Imaging and Laser Speckle Imaging Receives: Device: Modulated Imaging and Laser Speckle Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Noninvasive burn wound severity assessment
Noninvasive burn wound severity assessment using noncontact optical device
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Burn MultipleStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Anthony Joseph Durkin, University of California, Irvine
- Investigators
- Anthony Durkin, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166893
- Sponsor's protocol ID
- 20097322
- Other IDs
- R01GM108634
- Status last verified
- Dec 2025
- First submitted
- 20 Jul 2010
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of Modulated Imaging and Laser Speckle Imaging to Determine Burn Wound Severity and Healing Potential
- ClinicalTrials.gov ID
- NCT01166893
- Acronym / sponsor ID
- 20097322
- Conditions
- Skin Burn Multiple
- Keywords
- burn wound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Mar 2010
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 21 Jul 2010 (estimated)
- 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.
According to the National Burn Repository 2007, the most common type of burn injury is a partial thickness burns. The current standard of care for partial thickness burns is two weeks of topical therapy and wound care. Burns that do not heal within two weeks undergo surgical excision and skin grafting.
Detailed description
Researcher can use the combination of Modulated Imaging and Laser Speckle Imaging can be used as an adjuvant to standard clinical evaluation to gauge burn wound and severity of infection. Researcher can image the burn wounds of and compare with current standard of care, clinical exam, and can use the outcomes information in terms of time to healing and treatment
Modulating Imaging is a noninvasive optical modality measure the metabolic functions of the burn wound.
Laser Speckle Imaging is a noninvasive optical modality can measure blood flow of burn wound.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Burn wound | – | Device: Modulated Imaging and Laser Speckle ImagingModulated Imaging and Laser Speckle Imaging |
Who may qualify
- Ages
- 1 minute and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population will be selected from University of California Irvine Medical Center Burn Unit.
Key inclusion criteria (2 listed)
- Male / female all age
- Subjects is an inpatient or out patient with burn wound
Key exclusion criteria (2 listed)
- Subjects cannot lied flat and still for the duration of the imaging
- Subjects pregnant.
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 |
|---|---|---|
| Modulated Imaging and Laser Speckle ImagingAlso: MI-LSI developed at UCI Beckman Laser Institutewound healing | Device | Burn wound |
Primary outcome
Noninvasive burn wound severity assessment
Time frame: 1 day
Noninvasive burn wound severity assessment using noncontact optical device
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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.
Anthony Durkin, PhD principal investigator
University of California, Irvine
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 Skin Burn Multiple, run by University of California, Irvine 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 10 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gordon Kennedy, PhD (949-824-4713, gordon.kennedy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Noninvasive burn wound severity assessment (time frame: 1 day). 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 10 Dec 2025.