Multi-center, prospective, interventional, uncontrolled open-label study evaluating the
real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg
ulcers, diabetic foot ulcers, pressure ulcers).
Device: KLOX LumiHeal BioPhotonic System
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Full eligibility criteria for NCT03021811
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Signed and dated written informed consent form;
Adult patient (at least 18 years old) having received a diagnosis of venous leg ulcer, diabetic foot ulcer or pressure ulcer by the Investigator;
The treating physician (investigator) believes the KLOX LumiHeal BioPhotonic System would be an appropriate option;
Both male and female patients must be willing to adhere to a medically-accepted birth control method during the course of the study;
Willingness to comply with study requirements (visits, treatments, etc.).
Female pregnant patient (by medical history or as ascertained by a pregnancy test);
Breast-feeding female patient;
Patients taking drugs/products (e.g., methotrexate, chemotherapy agents) or with conditions (e.g., porphyria) known to induce severe photosensitivity reactions;
Patients with known skin hypersensitivity.
All locations for NCT03021811
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Tris trial is registered with FDA with number: NCT03021811. The sponsor of the trial is KLOX Technologies Inc. and it is looking for 100 volunteers for the current phase.
Official trial title: EUREKA Italy - The Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management: a Reproducibility Study
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