Clinical Effectiveness of DermACELL AWM in Subjects With Chronic Venous Leg Ulcers

This study is a multicenter, randomized, controlled, open-label trial designed to evaluate
the safety and efficacy of DermACELL in subjects with a single target chronic venous leg
ulcer (VLU). After eligibility is determined at a screening visit, VLU subjects will be
entered into a 2 week run-in period of conventional wound care with moist wound therapy and
multilayer compression bandage.

At baseline, those continuing to meet eligibility criteria will be randomized to either
DermACELL or conventional care wound management at a ratio of 1:1. The appropriate size of
DermACELL will be applied to the wound of subjects in the DermACELL arm. The ADM will be
attached with sutures, sterile adhesive strips, or bioadhesive, and covered with a dressing.
For subjects in the conventional care wound management arm, the debrided wound will undergo a
moist-wound therapy consisting of alginates, foams, or hydrogels, and will be covered with a
gauze that is appropriate for the type of wound (moist or dry).

Subsequent study visits will occur every week until 100% re-epithelialization or up to 16
weeks after treatment (whichever comes first).

Inclusion Criteria:

- Have been on a stable anti-diabetic treatment for at least 30 days before the baseline
visit if the subject has a diagnosis of Type 1 or Type 2 diabetes as defined by the
American Diabetes Association

- Have a full-thickness venous leg ulcer that does not penetrate into the muscle, tendon
or bone.

- Have a single target ulcer

- Have a wound with an area greater than or equal to 1 cm2 and less than 25 cm2 and a
depth less than or equal to 9 mm

- Have a venous stasis ulcer that has been present for at least 30 days.

- Have a Clinical severity, Etiology or cause, Anatomy and Pathophysiology ulcer
classification (CEAP) Grade C6: an open venous ulcer

- Have an absence of infection based on Infectious Disease Society of America criteria

- Have adequate circulation to the affected lower extremity, defined as an
Ankle-brachial index (ABI) greater than 0.75.

- Have the ability to comply with off-loading (if required for specific wound),
compression and dressing change requirements

- Have the ability to understand the requirements of the study, have provided written
informed consent as evidenced by signature on an informed consent form (ICF) approved
by an institutional review board (IRB), and agree to abide by the study restrictions
and return to the site for the required assessments

- Have provided written authorization for use and disclosure of protected health
information

- Have a life expectancy of greater than 6 months

Exclusion Criteria:

- Be pregnant or lactating

- Have a venous leg ulcer on the dorsum of the foot or more than 50% of the ulcer is
below the malleolus

- Have circulating hemoglobin A1c exceeding 12% within 90 days of the screening visit

- Have serum creatinine concentrations of 3.0 mg/dL or greater within 30 days prior to
screening

- Have a sensitivity to either of the following antibiotics: lincomycin, gentamicin,
polymyxin B, or vancomycin

- Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol

- Have the wound treated with biomedical or topical growth factors within the previous
30 days before the screening visit

- Need for any additional concomitant dressing material other than the ones approved for
this study

- Have clinical signs of an infection at the study ulcer site

- Have the inability to tolerate compression bandage

- Have a known or suspected disease of the immune system

- Have an active or untreated malignancy or active, uncontrolled connective tissue
disease

- Had a treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or
systemic corticosteroids less than 30 days before the baseline visit

- Have presence of necrosis, purulence, or sinus tracts that cannot be removed by
debridement

- Has undergone a revascularization procedure aimed at increasing blood flow in the
treatment target limb less than 4 weeks before the baseline visit

- Have serum aspartate aminotransferase, alanine aminotransferase, or alkaline
phosphatase levels greater than three times the normal upper limit within 30 days
prior to screening

- Have active Charcot disease

- Have undergone treatment with a living skin equivalent within the last 4 weeks before
the screening visit

- Have ongoing evidence of peripheral vascular disease, including greater than one
nonpalpable pulse on either foot

- Have the presence of any condition that in the opinion of the investigator places the
subject at undue risk or potentially jeopardizes the quality of the data to be
generated