Venous Leg UlcerNCT03593369
Assessment of the Evolution of Wound Biomarkers in Venous Leg Ulcers Treated With KLOX Biophotonic System
A study testing KLOX BioPhotonic System (single treatment)+SOC and KLOX BioPhotonic System (consecutive treatments)+SOC in people with Venous Leg Ulcer, run by KLOX Technologies Inc. at 1 site in Italy.
Trial summary
The main purpose of the study is to evaluate the effect of KLOX BioPhotonic System (composed of KLOX LumiHeal Gel and KT-L Lamp) on the expression of wound biomarkers in the treatment of venous leg ulcers (VLU). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- KLOX BioPhotonic System (single treatment)+SOC and KLOX BioPhotonic System (consecutive treatments)+SOC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jul 2018to Jun 2020
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 to 85 years of age, ambulatory or hospitalized patients;
- Patient agrees to participate in protocol schedule of visits, including follow-up evaluations;
- Patient to be enrolled must be able to adhere to the Standard of Care and to the treatments with the KLOX LumiHeal™ Gel and the KT-L Lamp described in the protocol;
- Patient or an authorised person must be able to read and understand informed consent, and sign or delegate signature of the informed consent form;
- Fitzpatrick skin type I to IV;
- Proven venous leg ulcer, clinically defined and confirmed by duplex, refilling time or venous hypertension;
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- Ulcer to be treated must be measurable and with an area between 5 and 100 cm2 inclusively, with a maximum depth of 1 cm and maximum diameter less or equal to 10 cm;
- If applicable, patients (male a female) must be willing to adhere to a medically-accepted birth control method (verified by the Investigator);
- Stable wound surface area with an absolute change in wound area less than 30% as measured at Baseline Visit compared to the Screening Visit.
Who cannot join
- Venous leg ulcer presents for less than 4 weeks or more than 18 months at Screening;
- The patient has more than one ulcer in the treated leg and the ulcer(s) not being assessed are within 5 cm of the targeted ulcer;
- The ulcer to be treated requires operative debridement or revascularization;
- The ulcer has significant necrotic tissue, as defined by more than 20% of the ulcer area after debridement;
- Major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, palliative care, or other chronic diseases such as lupus or sickle cell anemia;
- Patient with known moderate to severe anemia;
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- Patient with history of malignancy within the wound or patient with prior diagnosis of malignant disease who is less than one year disease-free;
- Patient who has experienced a hip fracture in the past 3 months;
- Patient with known osteomyelitis or active cellulitis;
- Patients who are immunosuppressed or on high dose of chronic steroid use (defined as oral dose of 7.5 mg or more of prednisone daily, or equivalent, for more than 28 days);
- Patient with active wound infection or with systemic infection (the patient is however eligible for re-screening after the active wound infection or the systemic infection has subsided);
- Successful revascularization surgery of the leg with the ulcer to be treated less than 8 weeks prior to Screening;
- Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study, or participation within the past 60 days in another interventional wound healing clinical trial;
- History of radiation therapy to the wound region;
- Pregnancy, or breast feeding;
- Patients with bleeding diathesis;
- Patients on an uncontrolled anti-coagulation therapy;
- The subject has any physical or psychiatric condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study;
- Concurrent disease or drugs known to induce severe photosensitivity of the skin, such as porphyria;
- Patient has received biological-based therapy, skin grafts or Negative Pressure Wound Therapy in the ulcer to be treated within last 3 months prior to Baseline.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Clinica Dermatologica Azienda Ospedaliero-Universitaria Pisana
Pisa, 56126
Valentina Dini, MD, dott.valentinadini@yahoo.it
About this study
Official title: A Prospective Controlled Randomized Clinical Study Exploring The Evolution Of Wound Biomarkers With TWO Dispensing Schedules Of The KLOX LumiHeal Gel And The KT-L Lamp Versus Standard Of Care In Venous Leg Ulcers
The main purpose of the study is to evaluate the effect of KLOX BioPhotonic System (composed of KLOX LumiHeal Gel and KT-L Lamp) on the expression of wound biomarkers in the treatment of venous leg ulcers (VLU). Patients will be randomized in three groups, two different dispensing schedules of KLOX BioPhotonic System in addition to Standard of Care (SOC) will be used, and SOC alone.
- Conditions
- Venous Leg Ulcer
- Being tested
- KLOX BioPhotonic System (single treatment)+SOC, KLOX BioPhotonic System (consecutive treatments)+SOC, Standard of Care (SOC)
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KLOX BioPhotonic System (single treatment)+SOCDevice
KLOX BioPhotonic system (composed of LumiHeal Gel and KT-L Lamp). In this study arm one treatment will be assessed - two visits per week.
Standard of Care (SOC) for wound healing will be administered during the treatment and follow-up periods (20 weeks).
KLOX BioPhotonic System (consecutive treatments)+SOCDevice
In this study arm, two consecutive treatments during the same visit will be evaluated- two visits for the first two weeks, then one visit per week.
Standard of Care (SOC) for wound healing will be administered during the treatment and follow-up periods (20 weeks).
Standard of Care (SOC)Other
Standard of Care (SOC) for wound healing will be administered during the treatment and follow-up periods (20 weeks).
| Study group | Role | What they receive |
|---|---|---|
| KLOX BioPhotonic System (single treatment)+SOC | Experimental | KLOX BioPhotonic System (LumiHeal Gel plus KLOX Multi-LED KT-L Lamp) will be administered twice weekly in association with SOC (10 patients) Receives: Device: KLOX BioPhotonic System (single treatment)+SOC |
| KLOX BioPhotonic System (consecutive treatments)+SOC | Experimental | KLOX BioPhotonic System (LumiHeal Gel plus KLOX Multi-LED KT-L Lamp) will be administered in two consecutive treatments (twice weekly on the first two weeks then once weekly) in association with SOC (10 patients) Receives: Device: KLOX BioPhotonic System (consecutive treatments)+SOC |
| Standard of Care | Active comparator | SOC only (5 patients) Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of biomarkers expression in biopsies and exudates of the venous leg ulcers.
Comparison of the expression of biomarkers in biopsies and exudates of the venous leg ulcers in the three treatment groups.
Measured: Up to 20 weeks
Secondary outcomes (1)
Adverse events, Serious adverse events, device incidents and compliance.
Number of adverse events, serious adverse events, device incidents and missed treatment visits.
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start9 Jul 2018
- Primary completionMar 2020 (estimated)
- Study completionJun 2020 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KLOX Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valentina Dini, MD, Principal investigator, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593369
- Sponsor's protocol ID
- CL-K1002-P013
- Status last verified
- Aug 2019
- First submitted
- 10 Jul 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Controlled Randomized Clinical Study Exploring The Evolution Of Wound Biomarkers With TWO Dispensing Schedules Of The KLOX LumiHeal Gel And The KT-L Lamp Versus Standard Of Care In Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT03593369
- Acronym / sponsor ID
- CL-K1002-P013
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- KLOX Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 20 Jul 2018 (actual)
- 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.
The main purpose of the study is to evaluate the effect of KLOX BioPhotonic System (composed of KLOX LumiHeal Gel and KT-L Lamp) on the expression of wound biomarkers in the treatment of venous leg ulcers (VLU). Patients will be randomized in three groups, two different dispensing schedules of KLOX BioPhotonic System in addition to Standard of Care (SOC) will be used, and SOC alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KLOX BioPhotonic System (single treatment)+SOC | Experimental | Device: KLOX BioPhotonic System (single treatment)+SOCKLOX BioPhotonic System (LumiHeal Gel plus KLOX Multi-LED KT-L Lamp) will be administered twice weekly in association with SOC (10 patients) |
| KLOX BioPhotonic System (consecutive treatments)+SOC | Experimental | Device: KLOX BioPhotonic System (consecutive treatments)+SOCKLOX BioPhotonic System (LumiHeal Gel plus KLOX Multi-LED KT-L Lamp) will be administered in two consecutive treatments (twice weekly on the first two weeks then once weekly) in association with SOC (10 patients) |
| Standard of Care | Active comparator | Other: Standard of Care (SOC)SOC only (5 patients) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female 18 to 85 years of age, ambulatory or hospitalized patients;
- Patient agrees to participate in protocol schedule of visits, including follow-up evaluations;
- Patient to be enrolled must be able to adhere to the Standard of Care and to the treatments with the KLOX LumiHeal™ Gel and the KT-L Lamp described in the protocol;
- Patient or an authorised person must be able to read and understand informed consent, and sign or delegate signature of the informed consent form;
- Fitzpatrick skin type I to IV;
Key exclusion criteria (20 listed)
- Venous leg ulcer presents for less than 4 weeks or more than 18 months at Screening;
- The patient has more than one ulcer in the treated leg and the ulcer(s) not being assessed are within 5 cm of the targeted ulcer;
- The ulcer to be treated requires operative debridement or revascularization;
- The ulcer has significant necrotic tissue, as defined by more than 20% of the ulcer area after debridement;
- Major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, palliative care, or other chronic diseases such as lupus or sickle cell anemia;
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 BioPhotonic System (single treatment)+SOCKLOX BioPhotonic system (composed of LumiHeal Gel and KT-L Lamp). In this study arm one treatment will be assessed - two visits per week. Standard of Care (SOC) for wound healing will be administered during the treatment and follow-up periods (20 weeks). | Device | KLOX BioPhotonic System (single treatment)+SOC |
| KLOX BioPhotonic System (consecutive treatments)+SOCIn this study arm, two consecutive treatments during the same visit will be evaluated- two visits for the first two weeks, then one visit per week. Standard of Care (SOC) for wound healing will be administered during the treatment and follow-up periods (20 weeks). | Device | KLOX BioPhotonic System (consecutive treatments)+SOC |
| Standard of Care (SOC)Standard of Care (SOC) for wound healing will be administered during the treatment and follow-up periods (20 weeks). | Other | Standard of Care |
Primary outcome
Assessment of biomarkers expression in biopsies and exudates of the venous leg ulcers.
Time frame: Up to 20 weeks
Comparison of the expression of biomarkers in biopsies and exudates of the venous leg ulcers in the three treatment groups.
1 secondary outcome
Adverse events, Serious adverse events, device incidents and compliance.
Time frame: Up to 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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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.
Valentina Dini, MD principal investigator
Azienda Ospedaliero, Universitaria Pisana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KLOX BioPhotonic System (single treatment)+SOC and KLOX BioPhotonic System (consecutive treatments)+SOC in people with Venous Leg Ulcer, run by KLOX Technologies Inc. at 1 site in Italy.
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 9 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephane Fauverghe, MD (450-680-4389, sfauverghe@kloxtechnologies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of biomarkers expression in biopsies and exudates of the venous leg ulcers. (time frame: Up to 20 weeks). 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 14 Aug 2019.