EUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management

EUREKA Italy - The Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management: a Reproducibility Study

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).

Inclusion Criteria:

• 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.).

Exclusion Criteria:

• 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.