Venous Leg UlcerNCT03021811
EUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management
A study testing KLOX LumiHeal BioPhotonic System in people with Venous Leg Ulcer and Diabetic Foot Ulcer, run by KLOX Technologies Inc..
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- What is being tested?
- KLOX LumiHeal BioPhotonic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.).
Who cannot join
- 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.
About this study
Official title: 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).
- Conditions
- Venous Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Being tested
- KLOX LumiHeal BioPhotonic System
- Medical subject headings
- Varicose Ulcer, Diabetic Foot, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KLOX LumiHeal BioPhotonic SystemDevice
Also called LumiHeal
Real-life use of KLOX LumiHeal BioPhotonic System in combination with standard of care.
| Study group | Role | What they receive |
|---|---|---|
| LumiHeal | Other | Treatment of chronic wounds with KLOX LumiHeal BioPhotonic System Receives: Device: KLOX LumiHeal BioPhotonic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, Serious Adverse Events and Device Incidents
Number of patients with adverse events, serious adverse events and device incidents.
Measured: Up to 34 weeks
Rate of complete wound closure
Measured: Up to 34 weeks
Secondary outcomes (5)
Wound area reduction over time
Measured: Up to 34 weeks
Time to complete wound closure
Measured: Up to 34 weeks
Incidence of wound breakdown, following wound closure
Measured: Up to 34 weeks
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.
Measured: Up to 34 weeks
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.
Measured: Up to 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startOct 2015
- Primary completionDec 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- KLOX Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021811
- Sponsor's protocol ID
- ORS-K1002-P001
- Status last verified
- Aug 2017
- First submitted
- 11 Jan 2017
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUREKA Italy - The Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management: a Reproducibility Study
- ClinicalTrials.gov ID
- NCT03021811
- Acronym / sponsor ID
- ORS-K1002-P001
- Conditions
- Venous Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- KLOX Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LumiHeal | Other | Device: KLOX LumiHeal BioPhotonic SystemTreatment of chronic wounds with KLOX LumiHeal BioPhotonic System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KLOX LumiHeal BioPhotonic SystemAlso: LumiHealReal-life use of KLOX LumiHeal BioPhotonic System in combination with standard of care. | Device | LumiHeal |
Primary outcome
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.
Rate of complete wound closure
Time frame: Up to 34 weeks
5 secondary outcomes
Wound area reduction over time
Time frame: Up to 34 weeks
Time to complete wound closure
Time frame: Up to 34 weeks
Incidence of wound breakdown, following wound closure
Time frame: Up to 34 weeks
Ease of use by healthcare professionals (questionnaire)
Time frame: Up to 34 weeks
Impact of treatment on Health-related Quality of Life (CWIS questionnaire)
Time frame: Up to 34 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing KLOX LumiHeal BioPhotonic System in people with Venous Leg Ulcer and Diabetic Foot Ulcer, run by KLOX Technologies Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events, Serious Adverse Events and Device Incidents (time frame: Up to 34 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.