Clinical trial NCT01824407: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetic Foot Ulcers
Keywords: foot
ulcers
diabetes
wound
healing
Lead sponsor: SANUWAVE, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-04
Enrollment: 90
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ulcers. This device generates acoustic (sound) pressure waves designed to act on the cells in your body to generate proteins that may lead to wound closure. The dermaPACE® device has not been approved for the treatment of diabetic foot ulcers; therefore its use in this study is investigational.

The purpose of the study is to evaluate the ability of the dermaPACE® device to help diabetic foot ulcers heal more quickly. The active study device, the dermaPACE®, will be compared to an inactive look-alike device (called a "Sham") in this study. The sham device will not provide any treatment to your diabetic foot ulcer.


Eligibility criteria: 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

Primary outcomes:
measure: Complete closure
timeFrame: 12 weeks
Secondary outcomes:
measure: Volumetric reduction
timeFrame: 12 weeks
measure: Area reduction
timeFrame: 12 weeks
measure: Rate of recurrence
timeFrame: 24 weeks
measure: Rate of amputation and other adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Associated Foot and Ankle Specialists
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Healthcare System
state: Arizona
city: Long Beach
country: United States
facility: Long Beach VA Healthcare System
state: California
city: Los Angeles
country: United States
facility: Foot and Ankle Clinic
state: California
city: Oakland
country: United States
facility: Alameda County Medical Center - Highlands Campus
state: California
city: San Bernardino
country: United States
facility: Lucius J. Hill DPM
state: California
city: Hialeah
country: United States
facility: Paul and Margaret Brand Research Center at Barry University
state: Florida
city: Hialeah
country: United States
facility: The Research Center
state: Florida
city: Jacksonville
country: United States
facility: River City Clinical Research
state: Florida
city: Miami
country: United States
facility: St. Paul Medical Research
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR
state: Florida
city: Chicago
country: United States
facility: Northwestern University, Div of Plastic and Reconstructive Surgery
state: Illinois
city: Southfield
country: United States
facility: Foot Healthcare Associates
state: Michigan
city: Asheville
country: United States
facility: Moore Foot and Ankle Specialists
state: North Carolina
city: Kittaning
country: United States
facility: Wound Center - ACMH
state: Pennsylvania
city: Dallas
country: United States
facility: Podiatric Medical Partners of Texas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Roanoke
country: United States
facility: Foot and Ankle Associates of SW Virginia
state: Virginia
city: Hamilton
country: Canada
facility: The Mayer Institute
state: Ontario
Study officials:
References: