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

NCT ID: NCT03021811

Last Updated: 2017-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-04-30

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).

Conditions

Venous Leg Ulcer; Diabetic Foot Ulcer; Pressure Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LumiHeal

Treatment of chronic wounds with KLOX LumiHeal BioPhotonic System

Group Type: OTHER

KLOX LumiHeal BioPhotonic System

Intervention Type: DEVICE

Real-life use of KLOX LumiHeal BioPhotonic System in combination with standard of care.

Interventions

KLOX LumiHeal BioPhotonic System

Real-life use of KLOX LumiHeal BioPhotonic System in combination with standard of care.

Intervention Type: DEVICE

Other Intervention Names

LumiHeal

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KLOX Technologies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ORS-K1002-P001

Identifier Type: -

Identifier Source: org_study_id