A Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns

Status unconfirmed · Not applicable

Conditions studied: Burn Wound

In brief

The primary purpose of this feasibility study is to evaluate safety and effectiveness in healing outcomes of patients treated with Lumina24TM BLU (treatment), a Continuous Low-Irradiance Phototherapy (CLIP) device, as compared to standard of care (SOC) therapy (control) for the treatment of acute burns.

Key facts

Study ID

NCT04011306

Run by

Rogers Sciences Inc.

People needed

15

Starts

2020-02-01

Expected to finish

2021-08-01

Last updated by the study team

2020-01-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females age > 18 to < 65
• BMI > 20 kg/m2
• Patients anticipated to receive inpatient care for a minimum of 72 hours at the respective medical facility for partial thickness second-degree, deep partial thickness second-degree and/or full thickness third-degree burn wounds.
• Patients who have a > 5% to < 50% Total Body Surface Area (TBSA) wound.
• Patients are willing and able to adhere to the therapy and protocol.
• Female of childbearing potential must be willing to use acceptable methods of contraception.
• Patients may or may not have clinical signs and symptoms of burn site infection at baseline.
• Subject has read, understood and signed the approved ICF before screening procedures either by the patient or their legally authorized representative.

You may not qualify if…

• Subjects with burns > third-degree (i.e. involvement of deeper tissues, such as muscle, tendons, or bone)
• Patients deemed not medically stable by the treating Investigator.
• Patients with burn wounds limited to their head or genitalia.
• Patients currently enrolled or participating in another investigational device, drug or biological trial that would interfere with the Lumina24TM application.
• Patients with inhalation burns.
• Patients who are clinically septic.
• Patients are pregnant.
• Patients on a ventilator, who are undergoing acute fluid resuscitation, are hemodynamically unstable or are deemed 'comfort measures only'.
• In the opinion of treating physician, patient not expected to survive beyond 30 days.
• Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at screening or baseline.
• Known history of HIV infection, or active Hepatitis B or Hepatitis C infection.
• Cancer requiring chemotherapy or radiation within previous 6 months or resection within the last 5 years (other than basal cell carcinoma.
• Known chronic renal failure (serum creatine > 2 mg/dL) or chronic liver disease.
• Pre-existing medical condition requiring current use of immunosuppressive medication or systemic steroids
• Pre-existing medical conditions that would interfere with wound healing (i.e. diabetic patients with Hemoglobin A1c test result > 8%, malignancy, autoimmune disease)
• Subjects with psychiatric conditions that are anticipated to result in protocol noncompliance
• Chronic illicit drug or alcohol abuse that is anticipated to interfere with patient compliance with the protocol
• Subject is incarcerated at the time of screening.

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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