A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers

Subjects will be considered for screening upon meeting initial eligibility criteria. After a
2 week screening period, subject will be randomized and enrolled if additional criteria is
met. In particular, if wound size has decreased by greater than 40%, subject will be
considered a screen fail and randomization will not take place. If all criteria including
wound size at Week 3 is met, subject will be randomized and enrolled. Subjects will return
weekly for a maximum of 12 weeks, or whenever healing occurs and then once more for a
confirmation of healing. Week 24 will consist of a phone call to the subject to complete QOL
surveys.

Inclusion Criteria:

- Men or women ≥ 18 years of age and able to give their own consent

- Type I or Type II diabetes with investigator-confirmed reasonable metabolic control

- Study ulcer has a Wagner grade of 1 or 2

- Study ulcer size of at least 1 cm2, but not exceeding 20 cm2 in area after debridement

- A full thickness diabetic foot ulcer located on the foot or ankle

- An ulcer which has been in existence for a minimum of 30 days, prior to the day of
screening.

Exclusion Criteria:

- Suspected or confirmed signs/symptoms of wound infection

- Wounds with exposed bone or tendon

- Hypersensitivity to bovine collagen