Status:
UNKNOWN
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
Lead Sponsor:
SANUWAVE, Inc.
Conditions:
Diabetic Foot Ulcers
Eligibility:
All Genders
22+ years
Phase:
PHASE3
Brief Summary
The Sponsor of this study, SANUWAVE, Inc., has developed an investigational device known as the dermaPACE® (Pulsed Acoustic Cellular Expression) device for the possible treatment of diabetic foot ulce...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01824407
Start Date
March 1 2013
Last Update
March 6 2014
Active Locations (19)
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1
Associated Foot and Ankle Specialists
Phoenix, Arizona, United States, 85015
2
Southern Arizona VA Healthcare System
Tucson, Arizona, United States, 85723
3
Long Beach VA Healthcare System
Long Beach, California, United States, 90822
4
Foot and Ankle Clinic
Los Angeles, California, United States, 90010