Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00536744
• Other study ID #: SAN07-DERM01
• 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

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

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

External Links

•   Company Web Site