Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03948360
Other study ID # BOS1705
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 7, 2017
Est. completion date December 31, 2019

Study information

Verified date May 2019
Source Rogers Sciences Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 21 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Shriners Hospitals for Children-Boston Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Rogers Sciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Pain as Assessed by Checklist Pain Behavior Scale To evaluate the change in participant's pain score during LIMB phototherapy treatment. Pain assessments taken daily at dressing change. up to 7 days
Primary Occurrence of Adverse Events from LIMB Phototherapy as Assessed by CTCAE v4.0 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. up to 7 days
Secondary Change in Bioburden assessed through Wound Culture 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. up to 7 days
See also
  Status Clinical Trial Phase
Completed NCT04277182 - Effect of Propolis Application on Burn Healing N/A
Enrolling by invitation NCT00978705 - Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood Phase 3
Withdrawn NCT03675568 - Non-cultured Autologous Keratinocyte Suspension Versus Traditional Split Skin Graft for Burn Wounds Treatment N/A
Active, not recruiting NCT04828304 - PLASOMA Ultimate Safety & Efficacy Study N/A
Not yet recruiting NCT05649332 - Study to Evaluate the Performance and Safety of the Medical Device Argogen N/A
Recruiting NCT05593523 - Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and Enhance Outcomes
Completed NCT06280053 - HealiAid in the Treatment of Different Wounds N/A
Enrolling by invitation NCT06103409 - MSCs for the Treatment of Burn Wounds Phase 1/Phase 2
Recruiting NCT05796492 - Ultrasound Treatment on Wound Healing Time N/A
Enrolling by invitation NCT04725071 - Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults N/A
Suspended NCT02577120 - Wound Healing Endpoint and Recurrence Phase 4
Active, not recruiting NCT05341427 - DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING N/A
Completed NCT04753723 - The Use of a Platform Wound Device for Reducing Infection Phase 4
Terminated NCT03723590 - A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix in Burn Patients for STSG N/A
Not yet recruiting NCT04011306 - A Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns N/A
Recruiting NCT05404191 - Prediction Rules for Low Level Laser on Burn Wounds N/A
Completed NCT02982096 - Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique N/A