A Double-Blind, Multi-center, Randomized, Sham-Controlled, Parallel Group 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

Date de début de l'étude : 1 mars 2013

Inclusion Criteria: Is >=22 years of age at Visit 1; 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; 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; 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. Has Type I or Type II Diabetes Mellitus with a HbA1c <= 11% at Visit 1; Is capable of wound care at home; Has a target ulcer >= 1.0 cm2 and <= 16 cm2 at Visits 1 and 2; 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 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; Subject agrees, or if applicable, the subject's legal representative agrees that the subject can participate in the study Exclusion Criteria: Is currently pregnant or plans to become pregnant during the study; Is nursing or actively lactating; Is morbidly obese (Body Mass Index >= 40) at Visit 1; Has clinically significant renal disease defined as having an estimated creatinine clearance of <=40mL/min at Visit 1; Has osteomyelitis in the foot or ankle on which the target ulcer is located at Visit 1 or 2; Has evidence of a prior ulcer in the same area as the target ulcer; Has a target ulcer that has decreased in volume by 50% or more at Visit 2 as compared to the volume at Visit 1; 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; Has a target ulcer that tunnels into wound tracks which cannot be fully visualized from the wound surface at Visit 1 or 2; Has active cellulitis either at the site of, or in the surrounding area of, the target ulcer at Visit 1 or 2; Has a target ulcer that has visually purulent exudates or that has malodorous exudates on examination at Visit 1 or 2; Has PVD, per Doppler Ultrasound, requiring vascular surgery intervention at Visit 1 or 2; 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; Has had a lower extremity revascularization procedure within eight weeks of Visit 1; Has active Charcot foot at Visit 1 or 2; Has had a surgical procedure to correct biomechanical abnormities within eight weeks of Visit 1; Has had a deep vein thrombosis within six months of Visit 1; Has clinical evidence of lymphedema at Visit 1; Has had chemotherapy within 60 days of Visit 1; Has a life expectancy <=2 years; Has previously participated in a dermaPACE diabetic foot ulcer study; Has had treatment of the target ulcer with growth factors, prostaglandin therapy, negative pressure or vasodilator therapy within two weeks of Visit 1; Is receiving >=10 mg/day of steroid therapy; Has sickle cell anemia; Has a known immunodeficiency disorder to include, but not be limited to: AIDS, HIV, etc. Has received radiation treatment within 120 days of Visit 1; Has received treatment with immunosuppressants within sixty days of Visit 1; Has received treatment with biologically active cellular products on the target ulcer, e.g. Apligraf®, Dermagraft®, etc. within sixty days of Visit 1; Has received treatment with acellular (collagen-based) products on the target ulcer, e.g. Alloderm®, Integra®, etc. within 30 days of Visit 1; Has a current history of substance abuse (current is defined as within 120 days of Visit 1); Has a history of major systemic infections requiring hospitalization within three months of Visit 1 ; 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; Has a physical or mental disability or geographical concerns that would inhibit compliance with required study visits; Is planning to undergo an exclusionary treatment or procedure during the study; or Has participated in another investigation within 30 days of Visit 1