Burn WoundNCT04011306
A Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns
A study testing Lumina24 BLU in people with Burn Wound, run by Rogers Sciences Inc. at 1 site in United States.
Trial summary
The primary purpose of this feasibility study is to evaluate safety and effectiveness in healing outcomes of patients treated with Lumina24TM BLU (treatment), a Continuous Low-Irradiance Phototherapy (CLIP) device, as compared to standard of care (SOC) therapy (control) for the treatment of acute burns. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burn Wound
- What is being tested?
- Lumina24 BLU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2020to Aug 2021
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females age > 18 to < 65
- BMI > 20 kg/m2
- Patients anticipated to receive inpatient care for a minimum of 72 hours at the respective medical facility for partial thickness second-degree, deep partial thickness second-degree and/or full thickness third-degree burn wounds.
- Patients who have a > 5% to < 50% Total Body Surface Area (TBSA) wound.
- Patients are willing and able to adhere to the therapy and protocol.
- Female of childbearing potential must be willing to use acceptable methods of contraception.
- Patients may or may not have clinical signs and symptoms of burn site infection at baseline.
- Subject has read, understood and signed the approved ICF before screening procedures either by the patient or their legally authorized representative.
Who cannot join
- Subjects with burns > third-degree (i.e. involvement of deeper tissues, such as muscle, tendons, or bone)
- Patients deemed not medically stable by the treating Investigator.
- Patients with burn wounds limited to their head or genitalia.
- Patients currently enrolled or participating in another investigational device, drug or biological trial that would interfere with the Lumina24TM application.
- Patients with inhalation burns.
- Patients who are clinically septic.
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- Patients are pregnant.
- Patients on a ventilator, who are undergoing acute fluid resuscitation, are hemodynamically unstable or are deemed 'comfort measures only'.
- In the opinion of treating physician, patient not expected to survive beyond 30 days.
- Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at screening or baseline.
- Known history of HIV infection, or active Hepatitis B or Hepatitis C infection.
- Cancer requiring chemotherapy or radiation within previous 6 months or resection within the last 5 years (other than basal cell carcinoma.
- Known chronic renal failure (serum creatine > 2 mg/dL) or chronic liver disease.
- Pre-existing medical condition requiring current use of immunosuppressive medication or systemic steroids
- Pre-existing medical conditions that would interfere with wound healing (i.e. diabetic patients with Hemoglobin A1c test result > 8%, malignancy, autoimmune disease)
- Subjects with psychiatric conditions that are anticipated to result in protocol noncompliance
- Chronic illicit drug or alcohol abuse that is anticipated to interfere with patient compliance with the protocol
- Subject is incarcerated at the time of screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida
Gainesville, Florida, 32610
David W. Mozingo, MD, 352-273-5670, david.mozingo@surgery.ufl.edu
About this study
Official title: A Multicenter, Prospective, Randomized, Comparative Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns
The primary purpose of this feasibility study is to evaluate safety and effectiveness in healing outcomes of patients treated with Lumina24TM BLU (treatment), a Continuous Low-Irradiance Phototherapy (CLIP) device, as compared to standard of care (SOC) therapy (control) for the treatment of acute burns.
Read the detailed description
This feasibility study will consist of up to 15 subjects (Cohort I: up to 10 subjects with partial thickness second-degree burns; Cohort II: up to 5 subjects with deep partial thickness second- and/or full thickness third-degree burns). Each subject will be randomized to receive standard of care dressing on approximately half of the study burn site, and Lumina24TM BLU treatment on the remaining half of the study burn site. If the subject has bilaterally symmetric burns, they will be randomized to receive SOC or Lumina24TM BLU at the distinct anatomical burn locations (e.g. right/left thigh, right/left shoulder, etc.). The proposed feasibility study will inform critical primary and secondary outcome measures and procedural improvements necessary for a pivotal clinical study that would demonstrate both antimicrobial effectiveness and improved wound healing of acute burn wounds.
- Conditions
- Burn Wound
- Being tested
- Lumina24 BLU
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumina24 BLUDevice
Lumina24 BLU is the technology used to deliver continuous low-irradiance phototherapy for the treatment of acute burns
| Study group | Role | What they receive |
|---|---|---|
| Lumina24 BLU | Experimental | Each subject will be randomized to receive standard of care dressing on approximately half of the study burn site, and Lumina24TM BLU treatment on the remaining half of the study burn site. Receives: Device: Lumina24 BLU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
Percentage area reduction (PAR) of the acute burn wound (SOC control site vs. Lumina24TM BLU treatment site)
Measured: up to 28 days
Number of adverse events
Safety measured by incidence of product-related AEs, SAEs, and UADEs
Measured: up to 28 days
Microbial load counts (Cohort II only)
Difference of bioburden in/on the burn wound (SOC control site vs. Lumina24TM BLU treatment site) assessed by quantitative analysis of microbial load counts obtained from 3-mm punch biopsies and wound cultures
Measured: up to 28 days
Secondary outcomes (4)
Time to healing
Time to burn wound healing at end of inpatient treatment
Measured: 12 months
Numerical Pain Rating Scale
Difference in pain related to acute burn wounds between SOC control site and Lumina24TM BLU treatment site assessed by patient-reported rating ranging from 0 to 10 (where 0 represents no pain and 10 represents worst possible pain)
Measured: 12 months
Cost-effectiveness
Difference in cost-effectiveness of treatment regime between Lumina24TM BLU and SOC control assessed by difference in sum of costs associated with each treatment regime (including costs of OR visits required, inpatient stay, grafts and/or biologics used)
Measured: 12 months
Patient and Observer Scar Assessment Scale
Difference in healing of hypertrophic scarring between SOC control site and Lumina24TM BLU treatment site assessed by Patient and Observer Scar Assessment Scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study startFeb 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rogers Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David W. Mozingo, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011306
- Sponsor's protocol ID
- CEP-06-001
- Status last verified
- Jan 2020
- First submitted
- 28 Jun 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Comparative Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns
- ClinicalTrials.gov ID
- NCT04011306
- Acronym / sponsor ID
- CEP-06-001
- Conditions
- Burn Wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Rogers Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 8 Jul 2019 (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.
The primary purpose of this feasibility study is to evaluate safety and effectiveness in healing outcomes of patients treated with Lumina24TM BLU (treatment), a Continuous Low-Irradiance Phototherapy (CLIP) device, as compared to standard of care (SOC) therapy (control) for the treatment of acute burns.
Detailed description
This feasibility study will consist of up to 15 subjects (Cohort I: up to 10 subjects with partial thickness second-degree burns; Cohort II: up to 5 subjects with deep partial thickness second- and/or full thickness third-degree burns). Each subject will be randomized to receive standard of care dressing on approximately half of the study burn site, and Lumina24TM BLU treatment on the remaining half of the study burn site. If the subject has bilaterally symmetric burns, they will be randomized to receive SOC or Lumina24TM BLU at the distinct anatomical burn locations (e.g. right/left thigh, right/left shoulder, etc.). The proposed feasibility study will inform critical primary and secondary outcome measures and procedural improvements necessary for a pivotal clinical study that would demonstrate both antimicrobial effectiveness and improved wound healing of acute burn wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumina24 BLU | Experimental | Device: Lumina24 BLUEach subject will be randomized to receive standard of care dressing on approximately half of the study burn site, and Lumina24TM BLU treatment on the remaining half of the study burn site. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females age > 18 to < 65
- BMI > 20 kg/m2
- Patients anticipated to receive inpatient care for a minimum of 72 hours at the respective medical facility for partial thickness second-degree, deep partial thickness second-degree and/or full thickness third-degree burn wounds.
- Patients who have a > 5% to < 50% Total Body Surface Area (TBSA) wound.
- Patients are willing and able to adhere to the therapy and protocol.
Key exclusion criteria (18 listed)
- Subjects with burns > third-degree (i.e. involvement of deeper tissues, such as muscle, tendons, or bone)
- Patients deemed not medically stable by the treating Investigator.
- Patients with burn wounds limited to their head or genitalia.
- Patients currently enrolled or participating in another investigational device, drug or biological trial that would interfere with the Lumina24TM application.
- Patients with inhalation burns.
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 |
|---|---|---|
| Lumina24 BLULumina24 BLU is the technology used to deliver continuous low-irradiance phototherapy for the treatment of acute burns | Device | Lumina24 BLU |
Primary outcome
Wound Healing
Time frame: up to 28 days
Percentage area reduction (PAR) of the acute burn wound (SOC control site vs. Lumina24TM BLU treatment site)
Number of adverse events
Time frame: up to 28 days
Safety measured by incidence of product-related AEs, SAEs, and UADEs
Microbial load counts (Cohort II only)
Time frame: up to 28 days
Difference of bioburden in/on the burn wound (SOC control site vs. Lumina24TM BLU treatment site) assessed by quantitative analysis of microbial load counts obtained from 3-mm punch biopsies and wound cultures
4 secondary outcomes
Time to healing
Time frame: 12 months
Numerical Pain Rating Scale
Time frame: 12 months
Cost-effectiveness
Time frame: 12 months
Patient and Observer Scar Assessment Scale
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
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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.
David W. Mozingo, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumina24 BLU in people with Burn Wound, run by Rogers Sciences 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 8 inclusion and 18 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 14 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing (time frame: up to 28 days). The study lists 3 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 14 Jan 2020.