NCT03948360

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

A First-In-Human Pilot Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Rogers Sciences Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Burn Wound

Interventions

Type	Name	Description
DEVICE	Low-Irradiance Monochromatic Biostimulation (LIMB) 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.
OTHER	Standard of Care	Standard of care therapy as defined for this clinical trial is standard gauze dressing soaked in Sulfamylon (mafenide acetate) solution.

Timeline

• Start date: 2017-09-07
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2019-05-13
• Last updated: 2019-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study