A Comparison of the dermaPACE® (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care Versus Standard of Care Alone in the Treatment of Diabetic Foot Ulcers

Inclusion Criteria:

1. Is >=22 years of age at Visit 1;

2. If female of child-bearing potential, both of the following must be met at Visit 1:

- Practices one of the following methods of contraception and continues through
the duration of the study: hormonal contraceptives, IUD, spermicide and barrier
or implantable device, and

- Has a negative urine qualitative beta-HCG pregnancy test;

3. If female and post-menopausal one of the following must be met at Visit 1:

- Has had a complete hysterectomy, bilateral salpingo-oophorectomy or tubal
ligation or otherwise be incapable of pregnancy, or

- Is postmenopausal for at least one year;

4. Has at least one DFU that is located in the ankle area or below that has persisted a
minimum of 30 days prior to Visit 1.

5. Has Type I or Type II Diabetes Mellitus with a HbA1c <= 11% at Visit 1;

6. Is capable of wound care at home;

7. Has a target ulcer >= 1.0 cm2 and <= 16 cm2 at Visits 1 and 2;

8. Has a target ulcer that is Grade 1 or 2, Stage A according to the University of Texas
Diabetic Wound Classification system, at Visits 1 and 2

9. In the leg with the target ulcer has an ABI >= 0.70 and <= 1.20 OR if the ABI is
>1.20 has a toe pressure >50 mmHg OR tcpO2 > 40 mmHg at Visit 1;

10. Subject agrees, or if applicable, the subject's legal representative agrees that the
subject can participate in the study

Exclusion Criteria:

1. Is currently pregnant or plans to become pregnant during the study;

2. Is nursing or actively lactating;

3. Is morbidly obese (Body Mass Index >= 40) at Visit 1;

4. Has clinically significant renal disease defined as having an estimated creatinine
clearance of <=40mL/min at Visit 1;

5. Has osteomyelitis in the foot or ankle on which the target ulcer is located at Visit
1 or 2;

6. Has evidence of a prior ulcer in the same area as the target ulcer;

7. Has a target ulcer that has decreased in volume by 50% or more at Visit 2 as compared
to the volume at Visit 1;

8. Has multiple foot ulcers that are connected by fistulas or has an ulcer(s) that are
within 5 cm of the target ulcer at Visit 1 or 2;

9. Has a target ulcer that tunnels into wound tracks which cannot be fully visualized
from the wound surface at Visit 1 or 2;

10. Has active cellulitis either at the site of, or in the surrounding area of, the
target ulcer at Visit 1 or 2;

11. Has a target ulcer that has visually purulent exudates or that has malodorous
exudates on examination at Visit 1 or 2;

12. Has PVD, per Doppler Ultrasound, requiring vascular surgery intervention at Visit 1
or 2;

13. Requires use of off-loading Diabetic Walker device for the foot intended for study
application for a reason other than for a target ulcer on the plantar surface of the
foot at Visit 1 or 2;

14. Has had a lower extremity revascularization procedure within eight weeks of Visit 1;

15. Has active Charcot foot at Visit 1 or 2;

16. Has had a surgical procedure to correct biomechanical abnormities within eight weeks
of Visit 1;

17. Has had a deep vein thrombosis within six months of Visit 1;

18. Has clinical evidence of lymphedema at Visit 1;

19. Has had chemotherapy within 60 days of Visit 1;

20. Has a life expectancy <=2 years;

21. Has previously participated in a dermaPACE diabetic foot ulcer study;

22. Has had treatment of the target ulcer with growth factors, prostaglandin therapy,
negative pressure or vasodilator therapy within two weeks of Visit 1;

23. Is receiving >=10 mg/day of steroid therapy;

24. Has sickle cell anemia;

25. Has a known immunodeficiency disorder to include, but not be limited to: AIDS, HIV,
etc.

26. Has received radiation treatment within 120 days of Visit 1;

27. Has received treatment with immunosuppressants within sixty days of Visit 1;

28. Has received treatment with biologically active cellular products on the target
ulcer, e.g. Apligraf®, Dermagraft®, etc. within sixty days of Visit 1;

29. Has received treatment with acellular (collagen-based) products on the target ulcer,
e.g. Alloderm®, Integra®, etc. within 30 days of Visit 1;

30. Has a current history of substance abuse (current is defined as within 120 days of
Visit 1);

31. Has a history of major systemic infections requiring hospitalization within three
months of Visit 1 ;

32. Has a current malignancy or a history of malignancy within five years, of Visit 1
except for basal cell carcinoma that has been treated with local excision and is no
longer present;

33. Has a physical or mental disability or geographical concerns that would inhibit
compliance with required study visits;

34. Is planning to undergo an exclusionary treatment or procedure during the study; or

35. Has participated in another investigation within 30 days of Visit 1