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

NCT03021811 | Completed

• 1 other identifier: ORS-K1002-P001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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)

  Up to 34 weeks

• Impact of treatment on Health-related Quality of Life (CWIS questionnaire)

  Up to 34 weeks

Study Arms (1)

LumiHeal

OTHER

Treatment of chronic wounds with KLOX LumiHeal BioPhotonic System

Device: KLOX LumiHeal BioPhotonic System

Interventions

KLOX LumiHeal BioPhotonic System DEVICE

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

Also known as: LumiHeal

LumiHeal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• KLOX Technologies Inc.: lead

MeSH Terms

Conditions

Varicose Ulcer; Diabetic Foot; Pressure Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 16, 2017
• Study Start: October 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08