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
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
1 other identifier
interventional
90
2 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
April 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedMarch 6, 2014
March 1, 2014
1.1 years
April 1, 2013
March 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete closure
Complete closure will be assessed by visual inspection by the principal or sub-investigator according to the following complete closure definition: 100% skin re-epithelializion without drainage or dressing requirements confirmed at two consecutive study visits. A re-epithelialized target ulcer is defined as the tissue surface having at least a thin layer of epithelium covering the prior, previously denuded, target ulcer area.
12 weeks
Secondary Outcomes (4)
Volumetric reduction
12 weeks
Area reduction
12 weeks
Rate of recurrence
24 weeks
Rate of amputation and other adverse events
24 weeks
Study Arms (2)
Active device plus standard of care
ACTIVE COMPARATORActive device plus standard of care
Sham device plus standard of care
SHAM COMPARATORdermaPACE device that uses a dummy applicator that does not emit shock waves
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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;
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SANUWAVE, Inc.lead
Study Sites (19)
Associated Foot and Ankle Specialists
Phoenix, Arizona, 85015, United States
Southern Arizona VA Healthcare System
Tucson, Arizona, 85723, United States
Long Beach VA Healthcare System
Long Beach, California, 90822, United States
Foot and Ankle Clinic
Los Angeles, California, 90010, United States
Alameda County Medical Center - Highlands Campus
Oakland, California, 94602, United States
Lucius J. Hill DPM
San Bernardino, California, 92404, United States
Paul and Margaret Brand Research Center at Barry University
Hialeah, Florida, 33013, United States
The Research Center
Hialeah, Florida, 33016, United States
River City Clinical Research
Jacksonville, Florida, 32207, United States
St. Paul Medical Research
Miami, Florida, 33126, United States
Advanced Pharma CR
Miami, Florida, 33137, United States
Northwestern University, Div of Plastic and Reconstructive Surgery
Chicago, Illinois, 60611, United States
Foot Healthcare Associates
Southfield, Michigan, 48076, United States
Moore Foot and Ankle Specialists
Asheville, North Carolina, 28806, United States
Wound Center - ACMH
Kittaning, Pennsylvania, 16201, United States
Podiatric Medical Partners of Texas
Dallas, Texas, 75224, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Foot and Ankle Associates of SW Virginia
Roanoke, Virginia, 24016, United States
The Mayer Institute
Hamilton, Ontario, L8R 2R3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2013
First Posted
April 4, 2013
Study Start
March 1, 2013
Primary Completion
April 1, 2014
Last Updated
March 6, 2014
Record last verified: 2014-03