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

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 hypoprotein…