Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers
Use of the dermaPACE™ (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care in the Treatment of Diabetic Foot Ulcers
1 other identifier
interventional
206
3 countries
23
Brief Summary
The purpose of this study is to compare the safety and effectiveness of the dermaPACE Device to sham application, when administered in conjunction with standard treatments used in the treatment of DFUs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2007
Typical duration for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2007
CompletedFirst Posted
Study publicly available on registry
September 28, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
April 14, 2014
CompletedApril 14, 2014
March 1, 2014
2.7 years
September 26, 2007
March 7, 2014
March 7, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
The Primary Variable for Effectiveness of the dermaPACE Device Will be Assessed by Comparing the Incidence of Complete Wound Closure of the dermaPACE and Control Groups 12 Weeks Post Initial Application.
12 weeks post initial application
Secondary Outcomes (1)
Time to Wound Closure, Wound Closure Area and Volume Between Active and Control 12 Weeks Post Initial Application, Subject Pain Assessment Between Active and Control 24 Weeks Post Initial Application
12 weeks post initial application and 24 weeks post initial application
Study Arms (2)
Active PACE application - 4 applications
ACTIVE COMPARATORApplication of acoustical pulse energy (extracorporeal shockwaves) to target ulcer + standard of care
Inactive, non-energy application
SHAM COMPARATORNon-energized (inactive - Sham)) application + standard of care
Interventions
Acoustical pulse energy (extracorporeal shockwave) + Standard of care wound dressing.
Non-energized (inactive - Sham) application + standard of care
Eligibility Criteria
You may qualify if:
- Male or female ≥ 18 years of age
- Diabetes mellitus
- One or more chronic foot ulcers (only one will be treated) that are located in the ankle area or below that has persisted a minimum of 30 days prior to the Screening visit
- HbA1c ≤ 12%
- Diabetic Foot Ulcers ≥ 1 cm2 and ≤ 16 cm2
- Ulcer Grade I or II, Stage A according to the University of Texas Diabetic Wound Classification system
- Ankle Brachial Index (ABI) ≥ 0.7 and ≤ 1.2, OR toe pressure \> 50 mmHg, OR tcPO2\> 40 mmHg.
You may not qualify if:
- Subject is morbidly obese (Body Mass Index ≥ 40)
- Subjects on dialysis
- Diagnosis of foot ulcer involving osteomyelitis
- Has evidence of prior ulcer in the same area
- Multiple diabetic foot ulcers on the foot that either are connected by fistulas or are within 5 cm of the target ulcer
- Subject's foot ulcer intended for study application has decreased in volume by 50% or more at the end of the two-week Run-in period as compared to the Screening visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SANUWAVE, Inc.lead
Study Sites (23)
Phoenix VA Health Care System
Phoenix, Arizona, 85012, United States
HOPE Research Insititute
Phoenix, Arizona, 85050, United States
Southern Arizona VA Healthcare System (SAVAHCS)
Tucson, Arizona, 85723, United States
Center for Clinical Research
Castro Valley, California, 94115, United States
Veterans Administration Long Beach Healthcare
Long Beach, California, 90822, United States
Olive View - UCLA Medical Center
Sylmar, California, 91342, United States
North American Center for Limb Preservation
New Haven, Connecticut, 06515, United States
Fairfield County Foot Surgeons
Norwalk, Connecticut, 06851, United States
Emory Orthopedic and Spine Center
Atlanta, Georgia, 30329, United States
Northwestern Univ. Div. of Plastic Surgery
Chicago, Illinois, 60611, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Center for Palliative Wound Care; Calvary Hospital
The Bronx, New York, 10461, United States
St. Vincent's Charity Hospital
Cleveland, Ohio, 44115, United States
Ohio State University
Columbus, Ohio, 43221, United States
Nashville Family Footcare
Nashville, Tennessee, 37203, United States
Richard Galperin, DPM, PA
Dallas, Texas, 75224, United States
Complete Family Foot Care
McAllen, Texas, 78501, United States
Robert Wunderlich, DPM, PA
San Antonio, Texas, 78212, United States
Aurora Health Care
Milwaukee, Wisconsin, 53215, United States
Mathias Spital
Rheine, 48431, Germany
Kings College Hospital
London, SE59RS, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Daniel Jorgensen, MD
- Organization
- SANUWAVE, Inc.
Study Officials
- STUDY DIRECTOR
Daniel Jorgensen, MD
SANUWAVE, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2007
First Posted
September 28, 2007
Study Start
October 1, 2007
Primary Completion
June 1, 2010
Study Completion
September 1, 2010
Last Updated
April 14, 2014
Results First Posted
April 14, 2014
Record last verified: 2014-03