Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers

Potential study candidates will be Screened for Inclusion and Exclusion criteria after
providing informed consent. Candidates will have their wound cleansed and debrided (if
necessary), photographed and measured. Blood will be drawn for laboratory analyses. Patients
will return two weeks later for assessment.

Upon return, per the original protocol, patient would have been randomized at <20% closure;
per Amendment 1, if the wound has closed <30% in area during the 2 week Screening Period and
all other eligibility criteria are met, the patient will be randomized (1:1) to receive
either AMNIOEXCEL® with Standard of Care (SOC) or SOC alone.

All patients enrolled in this study will receive SOC. For the purposes of this study,
Standard of Care (SOC) includes debridement of necrotic/non-viable tissue, moist wound
dressings, off-loading (where appropriate, DH Walker only) and infection surveillance and
management. For those randomized to receive AMNIOEXCEL®, in addition to SOC, the tissue will
be applied after the wound has been debrided and hemostasis achieved. The wound will then be
dressed with a non-adherent dressing (e.g. Adaptic) and covered with a moisture retentive
dressing.

The patient will return once weekly for wound care, photographs and ulcer measurement. At
each visit, the wound will be assessed and AMNIOEXCEL® reapplied as appropriate, based upon
physician judgment. All patients complete their participation at Week 6.

This is an open label study and no attempt will be made to blind subjects or Investigators to
randomization allocation.

Inclusion Criteria:

1. an ambulatory person at least 18 years of age at the time of informed consent.

2. type 1 or type 2 diabetes mellitus.

3. glycosylated hemoglobin (HbA1c) of ≤12%

4. at least one wound that is/has:

- Wagner grade 1 or superficial 2 (without bone, tendon or joint exposure),

- duration of at least 1 month,

- no clinical signs of infection or osteomyelitis,

- between 1cm2 and 25cm2 in area,

- per original protocol, closed <20% in area during the Screening Period; per
Amendment #1, closed <30% in area during Screening and

- located on the foot, distal to malleoli.

5. adequate circulation to the affected extremity

6. serum creatinine of <3.0mg/dl.

Exclusion Criteria:

1. participated in another clinical trial within 30 days prior to consent,

2. Active Charcot deformity of the study foot (i.e. erythematous, warm, edematous and
actively remodeling)

3. receiving radiation or chemotherapy of any kind,

4. known or suspected malignancy of current ulcer,

5. pregnant or breast feeding,

6. an active malignant disease,

7. receiving hemo- or peritoneal dialysis,

8. sickle cell anemia or Raynaud's syndrome,

9. diagnosis of autoimmune connective tissue disease,

10. received a biologic agent, growth factor, xenograft or skin equivalent in the 30 days
prior to consent,

11. exposed bone, tendon or joint capsule in the study ulcer,

12. currently receiving antibiotics (for any reason), or

13. taking medications considered to be immune system modulators.