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

Study Overview
=================
Brief 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.

Official Title
-----------------
A Prospective Case Series Evaluating the Safety of the KLOX BioPhotonic System in Stage II and III Pressure Ulcers

Conditions
-----------------
Pressure Ulcers Stage II, Pressure Ulcers Stage III

Intervention / Treatment
-----------------
* Device: KLOX BioPhotonic System


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KLOX BioPhotonic System<br>Treatment with KLOX BioPhotonic System in adjunction to Standard Of Care for pressure ulcers. | Device: KLOX BioPhotonic System<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 weeks | 
| Rate of complete wound closure. |  | 24 weeks | 
| Time to complete wound closure. |  | 24 weeks | 
| Incidence of wound breakdown. |  | 24 weeks | 
| Wound area reduction over time. |  | 24 weeks | 
| Wound volume reduction over time. |  | 24 weeks |