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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021811
• Other study ID #: ORS-K1002-P001
• Status: Completed
• Phase: N/A
• First received: January 11, 2017
• Last updated: August 15, 2017
• Start date: October 2015
• Est. completion date: April 2017

Study information

• Verified date: August 2017
• Source: KLOX Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Leg Ulcer
• Pressure Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KLOX Technologies Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, Serious Adverse Events and Device Incidents	Number of patients with adverse events, serious adverse events and device incidents.	Up to 34 weeks
Primary	Rate of complete wound closure		Up to 34 weeks
Secondary	Wound area reduction over time		Up to 34 weeks
Secondary	Time to complete wound closure		Up to 34 weeks
Secondary	Incidence of wound breakdown, following wound closure		Up to 34 weeks
Secondary	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
Secondary	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