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

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