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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SANUWAVE, Inc.
ClinicalTrials.gov Identifier:
NCT00536744
First received: September 26, 2007
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Diabetic Foot Ulcers
Device: acoustical pulse energy (extracorporeal shockwave)
Other: Sham
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Use of the dermaPACE™ (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care in the Treatment of Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by SANUWAVE, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 weeks post initial application ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 12 weeks post initial application and 24 weeks post initial application ] [ Designated as safety issue: No ]

Enrollment: 206
Study Start Date: October 2007
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536744

  Show 23 Study Locations
Sponsors and Collaborators
SANUWAVE, Inc.
Investigators
Study Director: Daniel Jorgensen, MD SANUWAVE, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: SANUWAVE, Inc.
ClinicalTrials.gov Identifier: NCT00536744     History of Changes
Other Study ID Numbers: SAN07-DERM01
Study First Received: September 26, 2007
Results First Received: March 7, 2014
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on September 11, 2014