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

August 15, 2017 updated by: KLOX Technologies Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: LumiHeal
Treatment of chronic wounds with KLOX LumiHeal BioPhotonic System
Device: KLOX LumiHeal BioPhotonic System
Real-life use of KLOX LumiHeal BioPhotonic System in combination with standard of care.
Other Names:
  • LumiHeal

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KLOX Technologies Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 13, 2017

First Posted (Estimate)

January 16, 2017

Study Record Updates

Last Update Posted (Actual)

August 18, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORS-K1002-P001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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