Pressure Ulcers Stage IINCT02222454
Safety Evaluation of the KLOX BioPhotonic System in Stage II and III Pressure Ulcers
A study testing KLOX BioPhotonic System in people with Pressure Ulcers Stage II and Pressure Ulcers Stage III, run by KLOX Technologies Inc. at 4 sites in Canada.
Trial summary
The primary objective of these case series is to evaluate the safety and tolerability of the KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with stage II or III pressure ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcers Stage II, Pressure Ulcers Stage III
- What is being tested?
- KLOX BioPhotonic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 4 sitesCanada
- Study dates
- Nov 2012to Aug 2015
- 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
- Male or female 18 years of age and older;
- The subject or legal guardian must have signed an informed consent form;
- Female of child bearing potential must have a negative pregnancy test result at Baseline and 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 return for all study visits;
- Stage II or III pressure ulcer (as per NPUAP Staging Guidelines), present for more than 4 weeks (up to Screening visit), located in the ischial, trochanteric, coccygeal, thoracic or abdominal regions. Lower extremity pressure ulcers, such as heel ulcers, are acceptable provided that diabetic foot ulcers are ruled out if the patient has diabetes. Surface dimensions of ulcer must be between 2 to 64 cm2 inclusive but longest diameter must not exceed 10 cm. Depth must not exceed 5 cm;
- Wound area has not changed by more than +/- 30% between Screening visit and Week 1/Visit 1 (before treatment).
Who cannot join
- Pressure ulcer present for more than 18 months;
- The ulcer to be treated is planned for operative debridement;
- The ulcer has significant necrotic tissue (e.g., more than 20% of the ulcer area);
- Major uncontrolled medical disorder(s) such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia;
- Severe or significant hypoalbuminemia (albuminemia < 30 g/L, and/or pre-albumin < 5 mg/dL), or hypoproteinemia (proteinemia < 55g/L);
- Patient with moderate to severe anemia (Hb < 90g/L);
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- Patient currently treated for an active malignant disease;
- Patient with history of malignancy within the wound;
- Patient with history of radiation therapy to the wound region;
- Patient with prior diagnosis of active malignant disease who is less than 1 year disease-free;
- Patient with a known osteomyelitis or active cellulitis;
- Patients that are immunosuppressed or on high dose chronic steroid use;
- Patients on systemic corticosteroids (a completion of corticosteroid course at least 30 days prior to study enrolment is required);
- Patient with active or systemic infection (note that the patient is however eligible for re-screening after the systemic infection has subsided);
- Patients with severely uncontrolled diabetes mellitus (defined as A1C > 12%);
- Dermatologic comorbid disease (e.g., cutis laxa or collagen vascular disease);
- Active bleeding;
- Pregnancy, or breast feeding;
- Patients with bleeding diathesis;
- Patients on Warfarin or IV Heparin;
- 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 (e.g., severe morbid obesity, recent hip fracture, suspected non-compliance, etc.);
- Patients with ulcers from burns (from exposure to high heat), venous ulcers or diabetic foot ulcers;
- Concurrent disease or drugs known to induce severe photosensitivity of the skin, such as porphyria;
- Patient has received biological-based therapy in any wound within 3 months of Screening;
- Concurrent participation in another clinical trial that involves an investigational drug or device that wound interfere with this study;
- Previous participation in other interventional wound healing clinical investigation within the 60 days prior to Screening visit.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Calgary Center for Clinical Research
Calgary, Alberta, T2N 4Z6
Queen's University
Kingston, Ontario, K7L 3N6
Lawton Health Research Institute
London, Ontario, N6C 2R5
St-Jerome Medical Research Inc.
Saint-Jérôme, Quebec, J7Z 5T3
About this study
Official title: A Prospective Case Series Evaluating the Safety of the KLOX BioPhotonic System in Stage II and III Pressure Ulcers
The primary objective of these case series is to evaluate the safety and tolerability of the KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with stage II or III pressure ulcers.
- Being tested
- KLOX BioPhotonic System
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KLOX BioPhotonic SystemDevice
KLOX BioPhotonic System (Multi-LED Light and KLOX Photo Converter Wound Gel) will be administered until wound closure or for a maximum of 16 weeks, followed by a 8-week follow-up period, in association with Standard Of Care for pressure ulcers.
| Study group | Role | What they receive |
|---|---|---|
| KLOX BioPhotonic System | Experimental | Treatment with KLOX BioPhotonic System in adjunction to Standard Of Care for pressure ulcers. Receives: Device: KLOX BioPhotonic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of the KLOX BioPhotonic System in patients with stage II or III pressure ulcers.
Occurrence of adverse events, serious adverse events and incidents; pain assessment with Visual Analog Scale; clinical laboratory parameters; vital signs; physical examination; percentage of patients with clinical infection requiring systemic antimicrobial therapy; concomitant medications and treatments.
Measured: 24 weeks
Secondary outcomes (6)
Optimal frequency of treatment with KLOX BioPhotonic System on stage II and III pressure ulcers.
Exploration of the optimal frequency of treatment with KLOX BioPhotonic System on stage II and III pressure ulcers, with dosing flexibility according to Investigator's clinical opinion.
Measured: 24 weeks
Rate of complete wound closure.
Measured: 24 weeks
Time to complete wound closure.
Measured: 24 weeks
Incidence of wound breakdown.
Measured: 24 weeks
Wound area reduction over time.
Measured: 24 weeks
Wound volume reduction over time.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startNov 2012
- Primary completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Ulcers Stage IIStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- KLOX Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Keast, Dr, Principal investigator, Lawton Research Institute, London, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222454
- Sponsor's protocol ID
- CL-K1002-P006
- Status last verified
- Feb 2016
- First submitted
- 19 Aug 2014
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Case Series Evaluating the Safety of the KLOX BioPhotonic System in Stage II and III Pressure Ulcers
- ClinicalTrials.gov ID
- NCT02222454
- Acronym / sponsor ID
- CL-K1002-P006
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- KLOX Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Aug 2015 (actual)
- First posted
- 21 Aug 2014 (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.
The primary objective of these case series is to evaluate the safety and tolerability of the KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with stage II or III 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 |
|---|---|---|
| KLOX BioPhotonic System | Experimental | Device: KLOX BioPhotonic SystemTreatment with KLOX BioPhotonic System in adjunction to Standard Of Care for pressure ulcers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female 18 years of age and older;
- The subject or legal guardian must have signed an informed consent form;
- Female of child bearing potential must have a negative pregnancy test result at Baseline and 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 return for all study visits;
- Stage II or III pressure ulcer (as per NPUAP Staging Guidelines), present for more than 4 weeks (up to Screening visit), located in the ischial, trochanteric, coccygeal, thoracic or abdominal regions. Lower extremity pressure ulcers, such as heel ulcers, are acceptable provided that diabetic foot ulcers are ruled out if the patient has diabetes. Surface dimensions of ulcer must be between 2 to 64 cm2 inclusive but longest diameter must not exceed 10 cm. Depth must not exceed 5 cm;
Key exclusion criteria (26 listed)
- Pressure ulcer present for more than 18 months;
- The ulcer to be treated is planned for operative debridement;
- The ulcer has significant necrotic tissue (e.g., more than 20% of the ulcer area);
- Major uncontrolled medical disorder(s) such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia;
- Severe or significant hypoalbuminemia (albuminemia < 30 g/L, and/or pre-albumin < 5 mg/dL), or hypoproteinemia (proteinemia < 55g/L);
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 SystemKLOX BioPhotonic System (Multi-LED Light and KLOX Photo Converter Wound Gel) will be administered until wound closure or for a maximum of 16 weeks, followed by a 8-week follow-up period, in association with Standard Of Care for pressure ulcers. | Device | KLOX BioPhotonic System |
Primary outcome
Safety and tolerability of the KLOX BioPhotonic System in patients with stage II or III pressure ulcers.
Time frame: 24 weeks
Occurrence of adverse events, serious adverse events and incidents; pain assessment with Visual Analog Scale; clinical laboratory parameters; vital signs; physical examination; percentage of patients with clinical infection requiring systemic antimicrobial therapy; concomitant medications and treatments.
6 secondary outcomes
Optimal frequency of treatment with KLOX BioPhotonic System on stage II and III pressure ulcers.
Time frame: 24 weeks
Rate of complete wound closure.
Time frame: 24 weeks
Time to complete wound closure.
Time frame: 24 weeks
Incidence of wound breakdown.
Time frame: 24 weeks
Wound area reduction over time.
Time frame: 24 weeks
Wound volume reduction over time.
Time frame: 24 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 23 Feb 2016.
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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.
David Keast, Dr principal investigator
Lawton Research Institute, London, Ontario, Canada
4 sites 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 in people with Pressure Ulcers Stage II and Pressure Ulcers Stage III, run by KLOX Technologies Inc. at 4 sites in Canada.
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 6 inclusion and 26 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 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
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?
Safety and tolerability of the KLOX BioPhotonic System in patients with stage II or III pressure ulcers. (time frame: 24 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 23 Feb 2016.