Burn WoundNCT03948360
Safety Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds
A study testing Low-Irradiance Monochromatic Biostimulation (LIMB) Device in people with Burn Wound, run by Rogers Sciences Inc. at 1 site in United States.
Trial summary
The primary purpose of this first-in-human, early feasibility study is to assess safety and feasibility of the Low-Irradiance Monochromatic Biostimulation (LIMB) System as a phototherapeutic intervention for the management of acute burn wounds. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Burn Wound
- What is being tested?
- Low-Irradiance Monochromatic Biostimulation (LIMB) Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2017to 31 Dec 2019
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients receiving care at Shriners Hospitals for Children-Boston for a skin tissue injury.
- Patients who have at least one wound with exposed area sufficient, in the Investigator's opinion, to receive LIMB therapy.
- Willing and able to adhere to daily LIMB therapy protocol.
Who cannot join
- Patients deemed not medically stable by the treating Investigator.
- Patients with clinical signs and symptoms of systemic infection at baseline.
- Patients with burn wounds limited to their head and genitalia.
- Patients who, in the opinion of the Investigator, will not require daily dressing changes.
- Patients receiving photosensitizing agents that result in cutaneous phototoxicity prior to enrollment. Patients who have received one or more of the following photosensitizers cannot be enrolled into the study: photofrin, amiodarone, chloropromazine, fluoroquinolone antibiotics, thiazide diuretics, quinine, demethylchlortetracycline, psoralens, nalidixic acid, tetracycline, naproxen.
- Patients currently enrolled or participating in another investigational device, drug or biological trial within 30 days of the Screening Visit.
- Patients currently receiving any bandages or devices containing silver compounds.
- Patients on a ventilator, who have fluid resuscitation or are in any terminal condition.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Shriners Hospitals for Children-Boston
Boston, Massachusetts, 02114
Robert L Sheridan, MD, 617-722-3000, rsheridan@partners.org
About this study
Official title: A First-In-Human Pilot Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds
The primary purpose of this first-in-human, early feasibility study is to assess safety and feasibility of the Low-Irradiance Monochromatic Biostimulation (LIMB) System as a phototherapeutic intervention for the management of acute burn wounds. The prototype LIMB device will be evaluated for the occurrence of adverse events (treatment-related or otherwise) of the LIMB System, a portable, wearable, light-emitting system developed by Rogers Sciences, Inc. (RSI). The device will be administered in the small feasibility pilot to confirm design, usability and operating specifications that will inform procedures and endpoints of a subsequent large, multicenter clinical trial.
- Conditions
- Burn Wound
- Being tested
- Low-Irradiance Monochromatic Biostimulation (LIMB) Device, Standard of Care
- Keywords
- acute burn, thermal injury, wound, phototherapy, wound healing, antimicrobial
- Medical subject headings
- Burns, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Irradiance Monochromatic Biostimulation (LIMB) DeviceDevice
The LIMB System is a portable and wearable phototherapeutic system that consists of a Light Patch and Power Pack. The Power Pack delivers power to the Light Patch, which attaches to the participant and emits blue spectrum (405nm low-irradiance) light. The Light Patch contains an array of thin optical arrays that evenly illuminate the surface. The Power Pack is powered by a Lithium Thionyl Chloride (Li-SOCI2) battery.
Standard of CareOther
Standard of care therapy as defined for this clinical trial is standard gauze dressing soaked in Sulfamylon (mafenide acetate) solution.
| Study group | Role | What they receive |
|---|---|---|
| LIMB Phototherapy with SOC | Experimental | Arm I: The first 3 participants enrolled will receive standard of care therapy under the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device. Receives: Device: Low-Irradiance Monochromatic Biostimulation (LIMB) Device; Other: Standard of Care |
| LIMB Phototherapy without SOC | Experimental | Arm II: The subsequent participants will receive only the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device without standard of care. Receives: Device: Low-Irradiance Monochromatic Biostimulation (LIMB) Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Adverse Events from LIMB Phototherapy as Assessed by CTCAE v4.0
To evaluate the occurrence of adverse events (treatment-related or otherwise) from LIMB phototherapy from the time of device application up to 7 days. Reporting consistent with CTCAE v4.0. Duration of LIMB phototherapy can be shortened per discretion of treating Investigator.
Measured: up to 7 days
Secondary outcomes (1)
Change in Bioburden assessed through Wound Culture
To evaluate the effect of LIMB phototherapy on microbial bioburden. Wound culture specimens are collected at each daily dressing change to measure the change in microbial bioburden when compared to baseline.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start7 Sep 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study model is sequential. Arm I will consist of the first 3 participants, with each participant receiving LIMB phototherapy over standard of care (SOC). The subsequent participants will comprise Arm II, with each participant to receive only LIMB phototherapy without standard of care. Dose modifications of the phototherapy can be made in Arm II, and will be determined based on any treatment-related adverse events observed in Arm I. Up to 12 participants in total will be enrolled.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rogers Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert L. Sheridan, MD, Principal investigator, Shriners Hospitals for Children-Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948360
- Sponsor's protocol ID
- BOS1705
- Status last verified
- May 2019
- First submitted
- 15 Nov 2018
- Last updated
- 13 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-Human Pilot Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds
- ClinicalTrials.gov ID
- NCT03948360
- Acronym / sponsor ID
- BOS1705
- Conditions
- Burn Wound
- Keywords
- acute burn, thermal injury, wound, phototherapy, wound healing, antimicrobial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Rogers Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 13 May 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 first-in-human, early feasibility study is to assess safety and feasibility of the Low-Irradiance Monochromatic Biostimulation (LIMB) System as a phototherapeutic intervention for the management of acute burn wounds. The prototype LIMB device will be evaluated for the occurrence of adverse events (treatment-related or otherwise) of the LIMB System, a portable, wearable, light-emitting system developed by Rogers Sciences, Inc. (RSI). The device will be administered in the small feasibility pilot to confirm design, usability and operating specifications that will inform procedures and endpoints of a subsequent large, multicenter clinical trial.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study model is sequential. Arm I will consist of the first 3 participants, with each participant receiving LIMB phototherapy over standard of care (SOC). The subsequent participants will comprise Arm II, with each participant to receive only LIMB phototherapy without standard of care. Dose modifications of the phototherapy can be made in Arm II, and will be determined based on any treatment-related adverse events observed in Arm I. Up to 12 participants in total will be enrolled.
| Arm | Type | Receives |
|---|---|---|
| LIMB Phototherapy with SOC | Experimental | Device: Low-Irradiance Monochromatic Biostimulation (LIMB) Device, Other: Standard of CareArm I: The first 3 participants enrolled will receive standard of care therapy under the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device. |
| LIMB Phototherapy without SOC | Experimental | Device: Low-Irradiance Monochromatic Biostimulation (LIMB) DeviceArm II: The subsequent participants will receive only the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device without standard of care. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients receiving care at Shriners Hospitals for Children-Boston for a skin tissue injury.
- Patients who have at least one wound with exposed area sufficient, in the Investigator's opinion, to receive LIMB therapy.
- Willing and able to adhere to daily LIMB therapy protocol.
Key exclusion criteria (8 listed)
- Patients deemed not medically stable by the treating Investigator.
- Patients with clinical signs and symptoms of systemic infection at baseline.
- Patients with burn wounds limited to their head and genitalia.
- Patients who, in the opinion of the Investigator, will not require daily dressing changes.
- Patients receiving photosensitizing agents that result in cutaneous phototoxicity prior to enrollment. Patients who have received one or more of the following photosensitizers cannot be enrolled into the study: photofrin, amiodarone, chloropromazine, fluoroquinolone antibiotics, thiazide diuretics, quinine, demethylchlortetracycline, psoralens, nalidixic acid, tetracycline, naproxen.
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 |
|---|---|---|
| Low-Irradiance Monochromatic Biostimulation (LIMB) DeviceThe LIMB System is a portable and wearable phototherapeutic system that consists of a Light Patch and Power Pack. The Power Pack delivers power to the Light Patch, which attaches to the participant and emits blue spectrum (405nm low-irradiance) light. The Light Patch contains an array of thin optical arrays that evenly illuminate the surface. The Power Pack is powered by a Lithium Thionyl Chloride (Li-SOCI2) battery. | Device | LIMB Phototherapy with SOC, LIMB Phototherapy without SOC |
| Standard of CareStandard of care therapy as defined for this clinical trial is standard gauze dressing soaked in Sulfamylon (mafenide acetate) solution. | Other | LIMB Phototherapy with SOC |
Primary outcome
Occurrence of Adverse Events from LIMB Phototherapy as Assessed by CTCAE v4.0
Time frame: up to 7 days
To evaluate the occurrence of adverse events (treatment-related or otherwise) from LIMB phototherapy from the time of device application up to 7 days. Reporting consistent with CTCAE v4.0. Duration of LIMB phototherapy can be shortened per discretion of treating Investigator.
1 secondary outcome
Change in Bioburden assessed through Wound Culture
Time frame: up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
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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.
Robert L. Sheridan, MD principal investigator
Shriners Hospitals for Children-Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Irradiance Monochromatic Biostimulation (LIMB) Device 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 3 inclusion and 8 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 13 May 2019. 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?
Occurrence of Adverse Events from LIMB Phototherapy as Assessed by CTCAE v4.0 (time frame: up to 7 days). 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 13 May 2019.