VLU Dressing Study

Design: This is an exploratory study in a single center, observer masked, active control,
randomized trial.

Overall, 30 subjects with VLU who have persistent wounds and have been previously treated
with silver based therapy will be 1:1 randomized to receive up to four applications over up
to four weeks of Study Device or Comparator (silver impregnated contact layer dressing -
Acticoat®) with 2 weeks follow up period.

Outcomes: Primary outcome is the change in bacterial load compared to baseline. Secondary
outcomes: healing rate, complete healing at 6 weeks, pain, quality of life (QOL) measurements
and adverse events.

Inclusion Criteria:

1. Adults, 18 years old and older (i.e. age ≥ 18 years).

2. Venous leg ulcer (VLU) is present on the leg. VLU shall be full thickness but without
exposure of deeper tissues (muscle bone or tendon).

3. If more than one ulcer is present, the largest ulcer meeting criteria shall be
designated the study ulcer.

4. If more than one ulcer on the study ulcer limb, study ulcer shall be at least one
centimeter from other ulcers.

5. Venous Doppler ultrasound exam, within one year from randomization, shall demonstrate
reflux of over 0.5 seconds in the affected limb.

6. Ankle-Brachial Pressure Index (ABI) exam with value of ≥0.80 in the affected limb

7. VLU has been treated with silver based therapy for at least 2 weeks within the
previous 6 months.

8. VLU present for at least one month prior to screening visit 1.

9. VLU at least 2 cm2 in size but not larger than 100 cm2.

10. After debridement, study ulcer demonstrates a clean wound bed.

11. If subject is a female of childbearing potential, subject must use at least one method
of contraception acceptable by PI such as birth control pills, IUD, condoms, or sexual
abstinence. At visit 1 urine pregnancy test must be negative.

12. Subject is able to comprehend all study related procedures and adhere to study
schedule.

13. Subject is able to provide written informed consent.

Exclusion Criteria:

1. Based on investigator medical judgment, ulcer is caused by any etiology exclusive of
venous insufficiency.

2. Study Ulcer surface area (post-debridement) has increased or decreased by more than
30% in the period between screening visit 1 and treatment visit 1.

3. Study Ulcer exhibits clinical signs and symptoms of infection in the period between
screening visit 1 and treatment visit 1 requiring oral antibacterial therapy.

4. Subject has known allergy to any of the materials used in the study.

5. Subject is unable to tolerate multi-layer compression therapy.

6. Basedoninvestigatormedicaljudgment,theStudyUlcerissuspiciousforcancer (e.g. basal cell
carcinoma or squamous cell carcinoma).

7. In the month prior to screening visit 1 subject was treated with systemic
immunosuppressive medications for more than 2 weeks (e.g. chemotherapy,
corticosteroids), and/or it is anticipated subject will require such medications
during study period.

8. In the month prior to screening visit 1 subject was enrolled in any other research
protocol for treatment of Study Ulcer.

9. The Subject has been diagnosed with malignant disease not in remission over the 5
years immediately preceding screening visit 1. (Except: cervical carcinoma in situ,
cutaneous squamous cell carcinoma, cutaneous basal cell carcinoma that have been
treated and have no evidence of recurrence or metastases).

10. Study ulcer area has been treated with radiation therapy at any time.

11. In the opinion of PI the subject has a medical condition such as autoimmune, renal,
hepatic or hematologic disease that makes the subject an inappropriate candidate for
participation in study.

12. In the month preceding screening visit 1 Study Ulcer has been treated with advanced
tissue engineered devices matrix based devices (e.g., ApligrafTM, DermagraftTM,
OasisTM).

13. Subject is diagnosed with New York Heart Association Class III and IV congestive
heart.

14. Failure: Class III: Symptoms with moderate exertion or, Class IV: Symptoms at rest.

15. Subject is diagnosed with diabetes mellitus that is poorly controlled and shall be
defined as hemoglobin A1C >10%.

16. Study Ulcer is completely or more than 50% of the Study Ulcer is located on the foot
(i.e. below the malleolus).

17. Subject is a female of childbearing potential, and refusing to use at least one method
of contraception acceptable by PI such as birth control pills, IUD, condoms, or sexual
abstinence.

18. Positive pregnancy test in screening visit 1 in a female of childbearing potential or
active pregnancy or breast-feeding.

19. In the opinion of the PI the subject is unable to understand or comply with study
related protocol including but not limited to providing informed consent.