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

Not Applicable

• Conditions: Burn Wound
• Interventions: Device: Low-Irradiance Monochromatic Biostimulation (LIMB) Device; Other: Standard of Care

• Registration Number: NCT03948360
• Lead Sponsor: Rogers Sciences Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-07
• Study First Submitted: 2018-11-15
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-10
• Last Update Submitted: 2019-05-10
• Study First Posted: 2019-05-13
• Last Update Posted: 2019-05-13
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LIMB Phototherapy without SOC	Low-Irradiance Monochromatic Biostimulation (LIMB) Device	Arm II: The subsequent participants will receive only the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device without standard of care.
LIMB Phototherapy with SOC	Low-Irradiance Monochromatic Biostimulation (LIMB) Device	Arm I: The first 3 participants enrolled will receive standard of care therapy under the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device.
LIMB Phototherapy with SOC	Standard of Care	Arm I: The first 3 participants enrolled will receive standard of care therapy under the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device.

Primary Outcome Measures

Name	Time	Method
Occurrence of Adverse Events from LIMB Phototherapy as Assessed by CTCAE v4.0	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 Outcome Measures

Name	Time	Method
Change in Bioburden assessed through Wound Culture	up to 7 days	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.

Trial Locations

Locations (1)

Shriners Hospitals for Children-Boston; 🇺🇸 Boston, Massachusetts, United States