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

Use of the dermaPACE™ (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care in the Treatment of Diabetic Foot Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Device: acoustical pulse energy (extracorporeal shockwave); Other: Sham

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.

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Rheine, Germany, 48431
    • Mathias Spital
• United Kingdom
  • London, United Kingdom, SE59RS
    • Kings College Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Phoenix VA Health Care System
    • Phoenix, Arizona, United States, 85050
      • HOPE Research Insititute
    • Tucson, Arizona, United States, 85723
      • Southern Arizona VA Healthcare System (SAVAHCS)
  • California
    • Castro Valley, California, United States, 94115
      • Center for Clinical Research
    • Long Beach, California, United States, 90822
      • Veterans Administration Long Beach Healthcare
    • Sylmar, California, United States, 91342
      • Olive View - UCLA Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06515
      • North American Center for Limb Preservation
    • Norwalk, Connecticut, United States, 06851
      • Fairfield County Foot Surgeons
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory Orthopedic and Spine Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Univ. Div. of Plastic Surgery
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • Bronx, New York, United States, 10461
      • Center for Palliative Wound Care; Calvary Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44115
      • St. Vincent's Charity Hospital
    • Columbus, Ohio, United States, 43221
      • Ohio State University
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Nashville Family Footcare
  • Texas
    • Dallas, Texas, United States, 75224
      • Richard Galperin, DPM, PA
    • McAllen, Texas, United States, 78501
      • Complete Family Foot Care
    • San Antonio, Texas, United States, 78212
      • Robert Wunderlich, DPM, PA
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active PACE application - 4 applications; Application of acoustical pulse energy (extracorporeal shockwaves) to target ulcer + standard of care	Device: acoustical pulse energy (extracorporeal shockwave); Acoustical pulse energy (extracorporeal shockwave) + Standard of care wound dressing.; Other Names: dermaPACE
Sham Comparator: Inactive, non-energy application; Non-energized (inactive - Sham)) application + standard of care	Other: Sham; Non-energized (inactive - Sham) application + standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: SANUWAVE, Inc.
• Investigators: Study Director: Daniel Jorgensen, MD, SANUWAVE, Inc.

Publications and helpful links

Helpful Links

• Company Web Site

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: September 26, 2007
• First Submitted That Met QC Criteria: September 26, 2007
• First Posted (Estimate): September 28, 2007

Study Record Updates

• Last Update Posted (Estimate): April 14, 2014
• Last Update Submitted That Met QC Criteria: March 7, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: SAN07-DERM01