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

Klox Technologies

Status

Completed

Conditions

Venous Leg Ulcer

Pressure Ulcer

Diabetic Foot Ulcer

Treatments

Device: KLOX LumiHeal BioPhotonic System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03021811

ORS-K1002-P001

Details and patient eligibility

About

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).

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.