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Clinical Studies

The dermaPACEā„¢ clinical trial has completed patient enrollment.

Diabetic Foot Ulcer

SANUWAVE, Inc. is conducting a global, pivotal Investigational Device Exemption (IDE) clinical study of the dermaPACETM device for the treatment of diabetic foot ulcers. The purpose of this study is to compare the safety and effectiveness of the dermaPACE device to placebo application when administered in conjunction with standard treatments of diabetic foot ulcers.

Placebo controlled, randomized, double blinded, prospective, multi-center trial
Up to 280 patients
Start date: September 2007

Primary Outcome Measures:

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.

Secondary Outcome Measures:
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.

Detailed Description:
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). This technology has also been shown in Europe to promote healing in several wound-healing applications and 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.

This study is intended to determine if dermaPACE offers 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.

Criteria for Inclusion in Study

Major Inclusion Criteria:
    •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
Major Exclusion Criteria:
    •Subject is morbidly obese (Body Mass Index ›40)
    •Subjects on hemodialysis
    •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 5cm 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


Study Sites

Locations:

Arizona:

Tucson
Dr. Katherine Neiderer
Southern Arizona VA Healthcare System
Contact Phone Number 520.907.3693

Phoenix
Dr. Robert G. Frykberg
Phoenix VA Health Care System
Contact Phone Number 602.277.5551

Phoenix and Scottsdale
Dr. Arthur Tallis
Hope Research Institute, LLC
Contact Phone Number 602.288.4673

California:

Castro Valley
Dr. Alexander Reyzelman
Center for Clinical Research
Contact Phone Number 510.581.1484

Long Beach
Dr. Ian Gordon
Long Beach VA Healthcare System
Contact Phone Number 562.826.5330

Sylmar
Dr. Peter Balingit
Olive View-UCLA Medical Center Department of Medicine
Contact Phone Number 818.364.3205

Connecticut:

New Haven
Dr. Peter Blume
North American Center for Limb Preservation
Contact Phone Number 203.397.0624

Norwalk
Dr. Andrew Rice
Fairfield County Foot Surgeons
Contact Phone Number 203.866.3377

Georgia:

Atlanta
Dr. Rami Calis
Emory Orthpaedic and Spine Center
Contact Phone Number 404.778.1566

Illinois:

Chicago
Dr. Robert Galiano
Northwestern University Feinberg School of Medicine, Division of Plastic Surgery
Contact Phone Number 312.695.6022
http://www.nmh.org/nmh/clinicaltrials/footulcer.htm

Massachusetts:

Boston
Dr. Adam Landsman
Beth Israel Deaconess Medical Center
Contact Phone Number 617.632.8473

Boston
Dr. Vicki Driver
Boston Medical Center
Contact Phone Number 617.414.6827

New York:

Bronx
Dr. Oscar Alvarez
Center for Palliative Wound Care
Contact Phone Number 718.518.2577

Ohio:

Cleveland
Dr. Catherine Hegarty
St. Vincent's Charity Hospital Wound Care Center
Contact Phone Number 440.884.1884

Columbus
Dr. Gayle Gordillo
Ohio State University Medical Center
Contact Phone Number 614.247.6755

Texas:

McAllen
Dr. Joseph Caporusso
Complete Family Foot Care
Contact Phone Number 956.971.9107

San Antonio
Dr. Robert Wunderlich
Contact Phone Number 210.281.9200

Dallas
Dr. Richard Galperin
Contact Phone Number 214.947.4583

Wisconsin:

Milwaukee
Dr. Jeffrey Niezgoda
Aurora Health Care
Contact Phone Number 414.649.6577

International

UK:
London
Professor Michael Edmonds
Kings College Hospital
Diabetic Foot Clinic
Contact Phone Number (+44) 203 299 3223

Germany:
Rheine
Professor Maximillian Spraul
Contact Phone Number 495971 46411

Reference: ClinicalTrials.gov, this record was processed on January 12, 2009. Please refer to this study by its ClinicalTrials.gov identifier: NCT00536744



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