DermACELL in Subjects With Chronic Wounds of the Lower Extremities

This study is designed to demonstrate the effectiveness of DermACELL in the treatment of
chronic wounds of the lower extremities. DermACELL will be compared to conventional care in
both subjects with diabetic foot ulcers (DFU) and subjects with venous stasis ulcers (VSU).
In addition, DermACELL will be compared to an active comparator, GraftJacket, in subjects
with diabetic foot ulcers.

DermACELL and GraftJacket are both made from donated human skin (dermis). These products have
been processed so that cells are removed and bacteria and viruses are destroyed. This
processing provided a supporting structure, an acellular dermal matrix, into which cells can
migrate and divide during the wound healing process.

Inclusion Criteria:

- Male and female between the ages of 21 and 80 that are able to provide informed
consent, are available for weekly clinic visits and are willing to comply with
off-loading requirements of treatment;

- If diabetic, have been on a stable dose of medication to treat diabetes for less than
30 days;

- Have a DFU that has been present for at least 30 days or have a VSU that has been
present for at least 60 days;

Exclusion Criteria:

- Have a DFU or VSU that is infected;

- Are pregnant or lactating;

- Have an allergy or are sensitive to one of the following antibiotics: lincomycin,
gentamicin, polymyxin B, or vancomycin;

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

- Have had a HbA1c level greater than 12% within the past 90 days;

- Have liver function tests or kidney function tests that are very elevated;

- Have a known or suspected disease of the immune system;

- Have had surgery in the past 30 days to increase blood flow into your leg or foot;

- Have cancer or a connective tissue disease (i.e. lupus, rheumatoid arthritis);

- Have undergone wound healing treatment with a living skin equivalent (i.e.,
Dermagraft®, Apligraf®, TheraSkin®, Oasis®, GraftJacket®, Integra®, Alloderm®) or
topical growth factors in the last 4 weeks;

- Have active Charcot disease, a weakening of the bones in the foot that can occur in
people who have significant nerve damage (neuropathy);