Recruiting

Wearable Phototherapy

Sponsor:

Rogers Sciences Inc.

Code:

NCT03948360

Conditions

Burn Wound

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Low-Irradiance Monochromatic Biostimulation (LIMB) Device

Standard of Care

Study Details

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.

Conditions

Burn Wound

Study ID

NCT03948360

Start date

Sep 7, 2017

Status verified date

May, 2019

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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

Enrollment

12 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Standard of Care

Standard of care therapy as defined for this clinical trial is standard gauze dressing soaked in Sulfamylon (mafenide acetate) solution.

Primary outcome measure

  • Occurrence of Adverse Events from LIMB Phototherapy as Assessed by CTCAE v4.0 [ Time Frame: up to 7 days ]

Central Contacts and Locations

Locations

Shriners Hospitals for Children-Boston

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Robert L Sheridan, MD

617-722-3000rsheridan@partners.org

More Information

Sponsor

Rogers Sciences Inc.

Last update posted

May 13, 2019

Last verified

May, 2019

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rogers Sciences Inc. on 2019-05-13.