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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00536744
Other study ID # SAN07-DERM01
Secondary ID
Status Completed
Phase Phase 3
First received September 26, 2007
Last updated March 7, 2014
Start date October 2007
Est. completion date September 2010

Study information

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

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
acoustical pulse energy (extracorporeal shockwave)
Acoustical pulse energy (extracorporeal shockwave) + Standard of care wound dressing.
Other:
Sham
Non-energized (inactive - Sham) application + standard of care

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
SANUWAVE, Inc.

Countries where clinical trial is conducted

United States,  Germany,  United Kingdom, 

Outcome

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
See also
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Completed NCT00013299 - Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3 Phase 2
Completed NCT00013286 - A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk Phase 2
Terminated NCT02667327 - A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer Phase 3
Not yet recruiting NCT00916292 - Safety Study of Topical Human FGF-1 for Wound Healing Phase 1
Completed NCT01154374 - A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot) Phase 2
Not yet recruiting NCT02672280 - Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects Phase 1/Phase 2

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