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