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Sponsored by: |
SANUWAVE, Inc. |
Information provided by: | SANUWAVE, Inc. |
ClinicalTrials.gov Identifier: | NCT00536744 |
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.
Condition | Intervention |
Diabetic Foot Ulcers |
Device: dermaPACE Other: Sham |
MedlinePlus related topics: | Diabetic Foot Foot Health |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Use of the dermaPACE™ (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care in the Treatment of Diabetic Foot Ulcers |
Estimated Enrollment: | 180 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
dermaPACE application + standard of care
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Device: dermaPACE
dermaPACE + Standard of care wound dressing.
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2: Sham Comparator
Non-energized (inactive) application + standard of care
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Other: Sham
Sham treatment + Standard of care wound dressing.
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The objective of this clinical study is to compare the safety and effectiveness of the dermaPACE (Pulsed Acoustic Cellular Expression) Device to sham application, when administered in conjunction with the standard of care, in the treatment of DFUs.
Diabetic patients are susceptible to chronic foot ulcerations due to the effects of the diabetic's systemic disease halting the wound healing process. In the United States, 20.8 million people with active diabetes, and 41 million with pre-diabetic symptoms account for $132 billion dollars in healthcare costs per year. In 2002, 82,000 non-traumatic lower-limb amputations were performed on diabetics, corresponding to 60% of all lower limb amputations, usually preceded by a non-healing foot ulceration. Given the magnitude of this disease and the long-term effects and morbidity of amputation, DFUs require immediate and aggressive treatment to ascertain the best possible outcome for the diabetic patient.
Despite the development of advanced wound care products, there is still a need to find the most effective treatment for reducing the time required to close a DFU. At any given time, 3-4% of diabetics (600,000 patients) have a foot ulcer, and $2.5 billion was spent in 2002 in the United States treating DFUs. The average cost for a single episode of a foot ulcer has been reported to be $4,595.00 to $28,691.00. Shock wave devices, which utilize acoustic pressure waves, have been used for about 30 years in urology for lithotripsy. In the last decade this technology has gained FDA approval to treat chronic plantar fasciitis and lateral epicondylitis conditions that do not respond to conservative treatments (OssaTron® SANUWAVE, manufacturer). Further, clinical reports have indicated efficacy in treating many other orthopedic conditions including pseudoarthroses, calcification of the joints and avascular necrosis. This technology has also been shown to promote healing in several wound-healing applications, and it is worthwhile to continue to seek the full potential of this technology in wound healing.
Acoustic pressure waves initiate a biological response at the cellular level-stimulating production of angiogenic growth factors, including endothelial nitric oxide synthase (ENOS), vascular endothelial growth factor (VEGF), and proliferating cell nuclear antigen (PCNA). These factors are important components of the normal wound healing process. This cellular activation and growth factor expression stimulated by acoustic pressure wave treatment could play a decisive role in overcoming cell quiescence and increasing growth factor titers to levels sufficient to overcome proteases. This leads to the in-growing of newly formed vessels, and the increased cellular proliferation and tissue regeneration needed to heal a wound.
Clinical publications have recently reported the pressure wave induced mechanism described above can initiate and accelerate healing in burns, traumatic wounds and reconstructive skin flaps, and diabetic wounds. A pilot study using the dermaPACE device, performed in nine diabetic subjects with chronic leg ulcers has shown that this technology in patients with a history of chronic ulcers may achieve wound closure. Treatment with dermaPACE has the added benefits of being non-invasive and devoid of significant clinical side effects. Therefore, the objective of this study is to examine the safety and effectiveness of the dermaPACE acoustic pressure wave treatment device in combination with standard of care for the treatment of foot ulcers in diabetic patients.
The dermaPACE should offer an improved non-invasive standard of care that may shorten an otherwise lengthy healing process and therefore make later operative measures unnecessary. Given that conservative therapy may not be effective, dermaPACE may become a preferable alternative that would carry minimal risk based on the expected clinical outcomes described in this protocol. dermaPACE may improve patient quality of life when conservative therapy is not effective as well as provide a cost savings for the health care system.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Major Inclusion Criteria:
Major Exclusion Criteria:
Contact: Naomi A. Sinclair, MBA | 678-578-0154 | Naomi.Sinclair@Sanuwave.com |
United States, Arizona | |||||
HOPE Research Insititute | Recruiting | ||||
Phoenix, Arizona, United States, 85050 | |||||
Contact: Nicole Marenco 602-288-4673 nicole.marenco@hriaz.com | |||||
Contact: Charanjit Singh 602-288-4673 | |||||
Principal Investigator: Arthur J. Tallis, DPM | |||||
Phoenix VA Health Care System | Recruiting | ||||
Phoenix, Arizona, United States, 85012 | |||||
Contact: Shannon Cook 602-277-5551 ext 6953 shannon.cook@va.gov | |||||
Principal Investigator: Robert G. Frykberg, DPM | |||||
United States, California | |||||
Center for Clinical Research | Recruiting | ||||
Castro Valley, California, United States, 94115 | |||||
Contact: Gayana Sarkisova 510-581-1484 | |||||
Contact: Gayana Sarkisova 415-292-0638 | |||||
Principal Investigator: Alexander Reyzelman, DPM | |||||
Olive View - UCLA Medical Center | Recruiting | ||||
Sylmar, California, United States, 91342 | |||||
Contact: Gus Chavez 818-364-3205 | |||||
Contact: Wendy Arriaga 310-916-7440 | |||||
Principal Investigator: Peter Balingit, MD | |||||
Veterans Administration Long Beach Healthcare | Recruiting | ||||
Long Beach, California, United States, 90822 | |||||
Contact: Reza Azadegan 562-826-8000 ext 2887 reza.azadegan@va.gov | |||||
Principal Investigator: Ian L Gordon, MD | |||||
United States, Connecticut | |||||
North American Center for Limb Preservation | Recruiting | ||||
New Haven, Connecticut, United States, 06515 | |||||
Contact: Sejal Patel 203-397-0624 drsejal79@yahoo.com | |||||
Principal Investigator: Peter A Blume, DPM | |||||
Fairfield County Foot Surgeons | Recruiting | ||||
Norwalk, Connecticut, United States, 06851 | |||||
Contact: Anne Rudick-Lowe 203-866-3377 alowe3@optonline.net | |||||
Principal Investigator: Andrew Rice, DPM | |||||
United States, Florida | |||||
Central Florida Foot and Ankle | Recruiting | ||||
Winter Haven, Florida, United States, 33881 | |||||
Contact: Lauren Smith 863-299-4551 doctors@flfootandankle.com | |||||
Contact: Mark Heck 863-299-4551 ext 122 mheck@flfootandankle.com | |||||
Principal Investigator: Tatiana Wellens-Bruschayt, DPM, PhD | |||||
Gulf Coast Footcare | Recruiting | ||||
Naples, Florida, United States, 34119 | |||||
Contact: Kellie Pelz 239-304-4791 Kellie.Pelz@pmc.hma.org | |||||
Contact: Michelle Malanga 239-348-4599 michelle.malanga@hma.org | |||||
Principal Investigator: Mickey Gordon, DPM | |||||
United States, Iowa | |||||
Amputation Prevention Center at Broadlawns Medical Center | Recruiting | ||||
Des Moines, Iowa, United States, 50314 | |||||
Contact: Catherine Griffis 515-282-2554 cgriffis@broadlawns.org | |||||
Principal Investigator: Lee Rogers, DPM | |||||
United States, Massachusetts | |||||
Beth Israel Deaconess Medical Center | Recruiting | ||||
Boston, Massachusetts, United States, 02215 | |||||
Contact: Valentina Conant 617-281-1780 vconant@bidmc.harvard.edu | |||||
Principal Investigator: Adam Landsman, DPM, PhD | |||||
United States, Minnesota | |||||
Mayo Clinic | Recruiting | ||||
Rochester, Minnesota, United States, 55905 | |||||
Contact: Eirik McFerrin, RN 507-538-7178 mcferrin.eirikbrennan@mayo.edu | |||||
Contact: Dawn Shelstad, RN 507-255-0473 dawn.shelstad@mayo.edu | |||||
Principal Investigator: Steven Kavros, DPM | |||||
United States, New York | |||||
Center for Palliative Wound Care; Calvary Hospital | Recruiting | ||||
Bronx, New York, United States, 10461 | |||||
Contact: Oscar Alvarez, PhD 718-518-2180 oalvarez@calvaryhospital.org | |||||
Principal Investigator: Oscar Alvarez, PhD | |||||
United States, Ohio | |||||
St. Vincent's Charity Hospital | Recruiting | ||||
Cleveland, Ohio, United States, 44115 | |||||
Contact: Carol Weikart, RN 216-363-2093 | |||||
Contact: Mary Miranda, RN 216-363-2646 | |||||
Principal Investigator: Catherine B. Hegarty, DPM | |||||
United States, Tennessee | |||||
Nashville Family Footcare | Recruiting | ||||
Nashville, Tennessee, United States, 37203 | |||||
Contact: Amanda Cash 615-327-2200 drmdaymedasst@bellsouth.net | |||||
Principal Investigator: Mardon Day, DPM | |||||
United States, Texas | |||||
Recruiting | |||||
San Antonio, Texas, United States, 78212 | |||||
Contact: Maribel Sauceda 210-281-9200 mari.sauceda@gmail.com | |||||
Principal Investigator: Robert Wunderlich, DPM | |||||
United States, Wisconsin | |||||
Aurora Health Care | Recruiting | ||||
Milwaukee, Wisconsin, United States, 53215 | |||||
Contact: Dawn Walek 414-385-2849 dawn.walek@aurora.org | |||||
Contact: Kathy Nelson, RN 414-385-8722 kathy.nelson@aurora.org | |||||
Principal Investigator: Jeffrey Niezgoda, MD |
SANUWAVE, Inc. |
Principal Investigator: | Arthur J. Tallis, DPM | Hope Research Institute |
Principal Investigator: | Alexander Reyzelman, DPM | Center for Clinical Research |
Principal Investigator: | Catherine B. Hegarty, DPM | St. Vincent's Charity Hospital |
Principal Investigator: | Peter Balingit, MD | Olive View-UCLA Medical Center |
Principal Investigator: | Robert G. Frykberg, DPM | Phoenix VA Health Care System |
Principal Investigator: | Jeffrey Niezgoda, MD | Aurora Health Care |
Principal Investigator: | Tatiana Wellens-Bruschayt, DPM, PhD | Central Florida Foot and Ankle |
Principal Investigator: | Oscar Alvarez, PhD | Center for Palliative Wound Care |
Principal Investigator: | Peter Blume, DPM | North American Center for Limb Preservation |
Principal Investigator: | Mardon Day, DPM | Nashville Family Footcare |
Principal Investigator: | Ian L Gordon, MD | VA Long Beach Healthcare System |
Principal Investigator: | Mickey Gordon, DPM | Gulf Coast Footcare |
Principal Investigator: | Steven Kavros, DPM | Mayo Clinic |
Principal Investigator: | Adam Landsman, DPM, PhD | Beth Isreal Deaconess Medical Center |
Principal Investigator: | Andrew Rice, DPM | Fairfield County Foot Surgeons |
Principal Investigator: | Lee Rogers, DPM | Amputation Prevention Center |
Principal Investigator: | Robert Wunderlich, DPM |
Company Web Site 
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Responsible Party: | SANUWAVE, Inc. ( Carolina DeDosantos, MPH, MBA - Senior Director, Clinical Trials ) |
Study ID Numbers: | SAN07-DERM01 |
First Received: | September 26, 2007 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00536744 |
Health Authority: | United States: Food and Drug Administration |
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