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

NCT ID: NCT00536744

Last Updated: 2014-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2010-09-30

Brief 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.

Detailed 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.

Conditions

Diabetic Foot Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active PACE application - 4 applications

Application of acoustical pulse energy (extracorporeal shockwaves) to target ulcer + standard of care

Group Type: ACTIVE_COMPARATOR

acoustical pulse energy (extracorporeal shockwave)

Intervention Type: DEVICE

Acoustical pulse energy (extracorporeal shockwave) + Standard of care wound dressing.

Inactive, non-energy application

Non-energized (inactive - Sham)) application + standard of care

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: OTHER

Non-energized (inactive - Sham) application + standard of care

Interventions

acoustical pulse energy (extracorporeal shockwave)

Acoustical pulse energy (extracorporeal shockwave) + Standard of care wound dressing.

Intervention Type: DEVICE

Sham

Non-energized (inactive - Sham) application + standard of care

Intervention Type: OTHER

Other Intervention Names

dermaPACE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SANUWAVE, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Jorgensen, MD

Role: STUDY_DIRECTOR

SANUWAVE, Inc.

Locations

Phoenix VA Health Care System

Phoenix, Arizona, United States

HOPE Research Insititute

Phoenix, Arizona, United States

Southern Arizona VA Healthcare System (SAVAHCS)

Tucson, Arizona, United States

Center for Clinical Research

Castro Valley, California, United States

Veterans Administration Long Beach Healthcare

Long Beach, California, United States

Olive View - UCLA Medical Center

Sylmar, California, United States

North American Center for Limb Preservation

New Haven, Connecticut, United States

Fairfield County Foot Surgeons

Norwalk, Connecticut, United States

Emory Orthopedic and Spine Center

Atlanta, Georgia, United States

Northwestern Univ. Div. of Plastic Surgery

Chicago, Illinois, United States

Boston Medical Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Center for Palliative Wound Care; Calvary Hospital

The Bronx, New York, United States

St. Vincent's Charity Hospital

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Nashville Family Footcare

Nashville, Tennessee, United States

Richard Galperin, DPM, PA

Dallas, Texas, United States

Complete Family Foot Care

McAllen, Texas, United States

Robert Wunderlich, DPM, PA

San Antonio, Texas, United States

Aurora Health Care

Milwaukee, Wisconsin, United States

Mathias Spital

Rheine, , Germany

Kings College Hospital

London, , United Kingdom

Countries

United States; Germany; United Kingdom

Related Links

http://www.sanuwave.com

Company Web Site

Other Identifiers

SAN07-DERM01

Identifier Type: -

Identifier Source: org_study_id