Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Irradiance Monochromatic Biostimulation (LIMB) Device | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain as Assessed by Checklist Pain Behavior Scale | To evaluate the change in participant's pain score during LIMB phototherapy treatment. Pain assessments taken daily at dressing change. | up to 7 days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert L. Sheridan, MD | Shriners Hospitals for Children-Boston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shriners Hospitals for Children-Boston | Recruiting | Boston | Massachusetts | 02114 | United States |
Not provided
| ID | Term |
|---|---|
| D002056 | Burns |
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| Standard of Care | Other | Standard of care therapy as defined for this clinical trial is standard gauze dressing soaked in Sulfamylon (mafenide acetate) solution. |
|