Back to resultsEUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management
Primary Purpose
Venous Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
KLOX LumiHeal BioPhotonic System
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcer
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
LumiHeal
Arm Description
Treatment of chronic wounds with KLOX LumiHeal BioPhotonic System
Outcomes
Primary Outcome Measures
Adverse events, Serious Adverse Events and Device Incidents
Number of patients with adverse events, serious adverse events and device incidents.
Rate of complete wound closure
Secondary Outcome Measures
Wound area reduction over time
Time to complete wound closure
Incidence of wound breakdown, following wound closure
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.
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.
Full Information
NCT ID
NCT03021811
First Posted
January 11, 2017
Last Updated
August 15, 2017
Sponsor
KLOX Technologies Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03021811
Brief Title
EUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management
Official Title
EUREKA Italy - The Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management: a Reproducibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KLOX Technologies Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LumiHeal
Arm Type
Other
Arm Description
Treatment of chronic wounds with KLOX LumiHeal BioPhotonic System
Intervention Type
Device
Intervention Name(s)
KLOX LumiHeal BioPhotonic System
Other Intervention Name(s)
LumiHeal
Intervention Description
Real-life use of KLOX LumiHeal BioPhotonic System in combination with standard of care.
Primary Outcome Measure Information:
Title
Adverse events, Serious Adverse Events and Device Incidents
Description
Number of patients with adverse events, serious adverse events and device incidents.
Time Frame
Up to 34 weeks
Title
Rate of complete wound closure
Time Frame
Up to 34 weeks
Secondary Outcome Measure Information:
Title
Wound area reduction over time
Time Frame
Up to 34 weeks
Title
Time to complete wound closure
Time Frame
Up to 34 weeks
Title
Incidence of wound breakdown, following wound closure
Time Frame
Up to 34 weeks
Title
Ease of use by healthcare professionals (questionnaire)
Description
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.
Time Frame
Up to 34 weeks
Title
Impact of treatment on Health-related Quality of Life (CWIS questionnaire)
Description
To collect quality of life data in patients treated with the KLOX LumiHeal BioPhotonic System.
Time Frame
Up to 34 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
EUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management
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