Safety Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds

Rogers Sciences

Status: Unknown

Conditions: Burn Wound

Treatments: Device: Low-Irradiance Monochromatic Biostimulation (LIMB) Device; Other: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT03948360

BOS1705

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

LIMB Phototherapy with SOC

Experimental group

Description:

Arm I: The first 3 participants enrolled will receive standard of care therapy under the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device.

Treatment:

Other: Standard of Care

Device: Low-Irradiance Monochromatic Biostimulation (LIMB) Device

LIMB Phototherapy without SOC

Experimental group

Description:

Arm II: The subsequent participants will receive only the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device without standard of care.

Treatment:

Device: Low-Irradiance Monochromatic Biostimulation (LIMB) Device