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

Not Applicable

Completed

• Conditions: Venous Leg Ulcer; Diabetic Foot Ulcer; Pressure Ulcer
• Interventions: Device: KLOX LumiHeal BioPhotonic System

• Registration Number: NCT03021811
• Lead Sponsor: KLOX Technologies Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2016-12
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-16
• Study Completion: 2017-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LumiHeal	KLOX LumiHeal BioPhotonic System	Treatment of chronic wounds with KLOX LumiHeal BioPhotonic System

Primary Outcome Measures

Name	Time	Method
Rate of complete wound closure	Up to 34 weeks
Adverse events, Serious Adverse Events and Device Incidents	Up to 34 weeks	Number of patients with adverse events, serious adverse events and device incidents.

Secondary Outcome Measures

Name	Time	Method
Ease of use by healthcare professionals (questionnaire)	Up to 34 weeks	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.
Incidence of wound breakdown, following wound closure	Up to 34 weeks
Impact of treatment on Health-related Quality of Life (CWIS questionnaire)	Up to 34 weeks	To collect quality of life data in patients treated with the KLOX LumiHeal BioPhotonic System.
Time to complete wound closure	Up to 34 weeks
Wound area reduction over time	Up to 34 weeks