Safety Evaluation of the KLOX BioPhotonic System in Stage II and III Pressure Ulcers

• Register: ClinicalTrials.gov
• Last refreshed on: 14 March 2016
• Main ID: NCT02222454
• Date of registration: 19/08/2014
• Prospective Registration: No
• Primary sponsor: KLOX Technologies Inc.
• Public title: Safety Evaluation of the KLOX BioPhotonic System in Stage II and III Pressure Ulcers
• Scientific title: A Prospective Case Series Evaluating the Safety of the KLOX BioPhotonic System in Stage II and III Pressure Ulcers
• Date of first enrolment: November 2012
• Target sample size: 3
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02222454
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: David Keast, Dr
• Affiliation: Lawton Research Institute, London, Ontario, Canada

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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);

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pressure Ulcers Stage II

Pressure Ulcers Stage III

Intervention(s)

Device: KLOX BioPhotonic System

Primary Outcome(s)

Safety and tolerability of the KLOX BioPhotonic System in patients with stage II or III pressure ulcers. [Time Frame: 24 weeks]

Secondary Outcome(s)

Rate of complete wound closure. [Time Frame: 24 weeks]

Wound volume reduction over time. [Time Frame: 24 weeks]

Time to complete wound closure. [Time Frame: 24 weeks]

Wound area reduction over time. [Time Frame: 24 weeks]

Incidence of wound breakdown. [Time Frame: 24 weeks]

Optimal frequency of treatment with KLOX BioPhotonic System on stage II and III pressure ulcers. [Time Frame: 24 weeks]

Secondary ID(s)

CL-K1002-P006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors