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

Study Overview
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Brief Summary
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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).

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

Conditions
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Venous Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer

Intervention / Treatment
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* Device: KLOX LumiHeal BioPhotonic System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LumiHeal<br>Treatment of chronic wounds with KLOX LumiHeal BioPhotonic System | Device: KLOX LumiHeal BioPhotonic System<br>* Real-life use of KLOX LumiHeal BioPhotonic System in combination with standard of care.<br>* Other names: LumiHeal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, Serious Adverse Events and Device Incidents | Number of patients with adverse events, serious adverse events and device incidents. | Up to 34 weeks | 
| Rate of complete wound closure |  | Up to 34 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound area reduction over time |  | Up to 34 weeks | 
| Time to complete wound closure |  | Up to 34 weeks | 
| Incidence of wound breakdown, following wound closure |  | Up to 34 weeks | 
| Ease of use by healthcare professionals (questionnaire) | To collect feedback on the ease of use of the KLOX LumiHeal BioPhotonic System in the management of chronic wounds, from health care professional users. | Up to 34 weeks | 
| Impact of treatment on Health-related Quality of Life (CWIS questionnaire) | To collect quality of life data in patients treated with the KLOX LumiHeal BioPhotonic System. | Up to 34 weeks |