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

• ClinicalTrials.gov Identifier: NCT03948360
• Recruitment Status: Unknown
• First Posted: May 13, 2019
• Last Update Posted: May 13, 2019
• Sponsor: Rogers Sciences Inc.
• Information provided by (Responsible Party): Rogers Sciences Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Burn Wound	Device: Low-Irradiance Monochromatic Biostimulation (LIMB) Device; Other: Standard of Care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: 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.
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: A First-In-Human Pilot Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds
• Actual Study Start Date: September 7, 2017
• Estimated Primary Completion Date: December 31, 2019
• Estimated Study Completion Date: December 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.
Experimental: LIMB Phototherapy without SOC; Arm II: The subsequent participants will receive only the Low-Irradiance Monochromatic Biostimulation (LIMB) phototherapy device without standard of care.	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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Change in Bioburden assessed through Wound Culture [ Time Frame: 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.

Other Outcome Measures:

1. Change in Pain as Assessed by Checklist Pain Behavior Scale [ Time Frame: up to 7 days ]
   To evaluate the change in participant's pain score during LIMB phototherapy treatment. Pain assessments taken daily at dressing change.

Eligibility Criteria

• Ages Eligible for Study: up to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Massachusetts

Shriners Hospitals for Children-Boston; Recruiting

Boston, Massachusetts, United States, 02114

Contact: Robert L Sheridan, MD 617-722-3000 rsheridan@partners.org

Sponsors and Collaborators

Rogers Sciences Inc.

Investigators

• Principal Investigator: Robert L. Sheridan, MD; Shriners Hospitals for Children-Boston

More Information

• Responsible Party: Rogers Sciences Inc.
• ClinicalTrials.gov Identifier: NCT03948360
• Other Study ID Numbers: BOS1705
• First Posted: May 13, 2019
• Last Update Posted: May 13, 2019
• Last Verified: May 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Rogers Sciences Inc.:

acute burn, thermal injury, wound, phototherapy, wound healing, antimicrobial

Additional relevant MeSH terms:

Wounds and Injuries; Burns