A First-In-Human Pilot Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Occurrence of Adverse Events from LIMB Phototherapy as Assessed by CTCAE v4.0
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- — to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
LIMB Phototherapy with SOC
Arm I: The first 3 participants enrolled will receive standard of care therapy under the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device.
Intervention: Low-Irradiance Monochromatic Biostimulation (LIMB) Device (Device)
LIMB Phototherapy with SOC
Arm I: The first 3 participants enrolled will receive standard of care therapy under the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device.
Intervention: Standard of Care (Other)
LIMB Phototherapy without SOC
Arm II: The subsequent participants will receive only the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device without standard of care.
Intervention: Low-Irradiance Monochromatic Biostimulation (LIMB) Device (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in Bioburden assessed through Wound Culture(up to 7 days)