Assessment of the Evolution of Wound Biomarkers in Venous Leg Ulcers Treated With KLOX Biophotonic System

Inclusion Criteria:

1. Male or female 18 to 85 years of age, ambulatory or hospitalized patients;

2. Patient agrees to participate in protocol schedule of visits, including follow-upevaluations;

3. Patient to be enrolled must be able to adhere to the Standard of Care and to thetreatments with the KLOX LumiHeal™ Gel and the KT-L Lamp described in the protocol;

4. Patient or an authorised person must be able to read and understand informed consent,and sign or delegate signature of the informed consent form;

5. Fitzpatrick skin type I to IV;

6. Proven venous leg ulcer, clinically defined and confirmed by duplex, refilling time orvenous hypertension;

7. Ulcer to be treated must be measurable and with an area between 5 and 100 cm2inclusively, with a maximum depth of 1 cm and maximum diameter less or equal to 10 cm;

8. If applicable, patients (male a female) must be willing to adhere to amedically-accepted birth control method (verified by the Investigator);

9. Stable wound surface area with an absolute change in wound area less than 30% asmeasured at Baseline Visit compared to the Screening Visit.

Exclusion Criteria:

1. Venous leg ulcer presents for less than 4 weeks or more than 18 months at Screening;

2. The patient has more than one ulcer in the treated leg and the ulcer(s) not beingassessed are within 5 cm of the targeted ulcer;

3. The ulcer to be treated requires operative debridement or revascularization;

4. The ulcer has significant necrotic tissue, as defined by more than 20% of the ulcerarea after debridement;

5. Major uncontrolled medical disorders such as serious cardiovascular, renal, liver orpulmonary disease, palliative care, or other chronic diseases such as lupus or sicklecell anemia;

6. Patient with known moderate to severe anemia;

7. Patient with history of malignancy within the wound or patient with prior diagnosis ofmalignant disease who is less than one year disease-free;

8. Patient who has experienced a hip fracture in the past 3 months;

9. Patient with known osteomyelitis or active cellulitis;

10. Patients who are immunosuppressed or on high dose of chronic steroid use (defined asoral dose of 7.5 mg or more of prednisone daily, or equivalent, for more than 28days);

11. Patient with active wound infection or with systemic infection (the patient is howevereligible for re-screening after the active wound infection or the systemic infectionhas subsided);

12. Successful revascularization surgery of the leg with the ulcer to be treated less than 8 weeks prior to Screening;

13. Concurrent participation in another clinical trial that involves an investigationaldrug or device that would interfere with this study, or participation within the past 60 days in another interventional wound healing clinical trial;

14. History of radiation therapy to the wound region;

15. Pregnancy, or breast feeding;

16. Patients with bleeding diathesis;

17. Patients on an uncontrolled anti-coagulation therapy;

18. The subject has any physical or psychiatric condition that, in the Investigator'sopinion, would warrant exclusion from the study or prevent the subject from completingthe study;

19. Concurrent disease or drugs known to induce severe photosensitivity of the skin, suchas porphyria;

20. Patient has received biological-based therapy, skin grafts or Negative Pressure WoundTherapy in the ulcer to be treated within last 3 months prior to Baseline.