Diabetic Foot Ulcers Clinical Trial
Official title:
Use of the dermaPACE™ (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care in the Treatment of Diabetic Foot Ulcers
Verified date | March 2014 |
Source | SANUWAVE, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 206 |
Est. completion date | September 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Mathias Spital | Rheine | |
United Kingdom | Kings College Hospital | London | |
United States | Emory Orthopedic and Spine Center | Atlanta | Georgia |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Boston Medical Center | Boston | Massachusetts |
United States | Center for Palliative Wound Care; Calvary Hospital | Bronx | New York |
United States | Center for Clinical Research | Castro Valley | California |
United States | Northwestern Univ. Div. of Plastic Surgery | Chicago | Illinois |
United States | St. Vincent's Charity Hospital | Cleveland | Ohio |
United States | Ohio State University | Columbus | Ohio |
United States | Richard Galperin, DPM, PA | Dallas | Texas |
United States | Veterans Administration Long Beach Healthcare | Long Beach | California |
United States | Complete Family Foot Care | McAllen | Texas |
United States | Aurora Health Care | Milwaukee | Wisconsin |
United States | Nashville Family Footcare | Nashville | Tennessee |
United States | North American Center for Limb Preservation | New Haven | Connecticut |
United States | Fairfield County Foot Surgeons | Norwalk | Connecticut |
United States | HOPE Research Insititute | Phoenix | Arizona |
United States | Phoenix VA Health Care System | Phoenix | Arizona |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Robert Wunderlich, DPM, PA | San Antonio | Texas |
United States | Olive View - UCLA Medical Center | Sylmar | California |
United States | Southern Arizona VA Healthcare System (SAVAHCS) | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
SANUWAVE, Inc. |
United States, Germany, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No |
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