Human Amniotic Membrane Grafting and Standard of Care Versus Standard of Care Alone in the Treatment of Venous Leg Ulcers

Inclusion Criteria:

- At least 18 years old

- Ankle Brachial Pressure Index (ABI) > 0.75

- Presence of a venous leg ulcer extending through the full thickness of the skin but
not down to muscle, tendon or bone

- Study ulcer has been present for at least one month prior to the initial screening
visit, and is excluded if it has undergone 12 months of continuous high strength
compression therapy over its duration

- Study ulcer is a minimum of 2 cm2 and a maximum of 20 cm2 at the Randomization visit

- The target ulcer has been treated with compression therapy for at least 14 days prior
to randomization

- Ulcer has a clean, granulating base with minimal adherent slough at the Randomization
visit

- Females of childbearing potential must be willing to use acceptable methods of
contraception (birth control pills, barriers, or abstinence).

- Patient understands and is willing to participate in the clinical study and can
comply with weekly visits and the follow-up regimen

- Patient has read and signed the IRB/IEC approved Informed Consent Form before
screening procedures are undertaken

Exclusion Criteria:

- Study ulcer(s) deemed by the investigator to be caused by a medical condition other
than venous insufficiency

- Study ulcer exhibits clinical signs and symptoms of infection.

- Non-mobile i.e. not ambulatory, or bed ridden

- Study ulcer, in the opinion of the investigator, is suspicious for cancer should
undergo an ulcer biopsy to rule out a carcinoma of the ulcer

- Patients with a history of more than two weeks treatment with immuno-suppressants
(including systemic corticosteroids), cytotoxic chemotherapy, or application of
topical steroids to the ulcer surface within one month prior to initial screening, or
who receive such medications during the screening period, or who are anticipated to
require such medications during the course of the study

- Patients on any investigational drug(s) or therapeutic device(s) within 30 days
preceding Screening

- History of radiation at the ulcer site

- Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.

- Study ulcer has been previously treated with tissue engineered materials (e.g.
Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within
the last 30 days

- Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the
course of the trial.

- Patients who are unable to understand the aims and objectives of the trial

- Presence of any condition(s) which seriously compromises the subject's ability to
complete this study, or has a known history of poor adherence with medical treatment

- NYHA Class III and IV congestive heart failure (CHF), as defined by the following
criteria: Class III: Symptoms with moderate exertion; Class IV: Symptoms at rest

- Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the
malleolus are excluded.

- Pregnant or breast feeding

- Currently taking medications which could affect graft incorporation.(supervising
physicians discretion)

- Allergic to gentamicin and streptomycin