AcuStep’s unique, customized approach to foot health is designed to be in partnership
with a patient’s existing family practitioner or other healthcare provider. Please contact
us to learn more about the AcuStep system and how we can help you with your patients.

Meet Dr. Fullen:

Jerry Fullen, MD – co-founder and developer of the patented FDA-registered
AcuStep Gait Force Analysis and DPRO™ Foot Orthotic System.

Background: As a board certified Orthopedic Surgeon, I practiced orthopedic
surgery full time for over 30 years until the Spring of 2009. During my practice
career, I helped manage the ravages of diabetes on the lower limb which ultimately
would frequently require an amputation at one or multiple levels. This was very
frustrating. It has been my long term goal to transition to a non-operative
preventive clinical practice in the areas of diabetic foot ulcer prevention, foot comfort
and sports performance using technology developed over the past decade by AcuStep
and several other companies.

History: In the early 90’s, my brother (an engineer) and I began discussions regarding
determination of foot pressures on the bottom (plantar) aspect of the foot during
one’s normal activity. I initially wanted to use this technology to assist in rehab of
lower extremity injuries. We reviewed the peer reviewed literature and the available
products before realizing that reliable and appropriate technology was not available.
We received our first US Patent regarding in-shoe foot pressure measurement Nov 1994.
About a year later, I noted that some of my patients were presenting with their bag of
shoes, various inserts (both hard and soft) and one more thing: persistent foot pain.
I realized that simply basing the orthotic solution on the shape of the plantar foot and
the characteristics of surface impact during the stance phases of gait was not enough.
I kept reading the peer reviewed literature and noted a number of articles re the
negative effect of high plantar foot pressures and even some articles on the effect of
shear foot pressures in diabetic neuropathy. It seemed reasonable that no matter what
footwear and orthotic construct, the patient would eventually have to impact the ground
during gait. It became apparent that mismanagement of peak ground reactive forces
(GRF) was the primary source of pain and injury depending on the magnitude,
persistence and location of peak GRF.

Development: But in order to make use of this patented technology, the next 10 years
was spent developing everything from the ground up to include an operational foot
sensor array, an array computer unit, a calibration system, dual axis router system for
orthotic fabrication and associated software applications for data collection, shape
generation and CNC orthotic fabrication. A Gait Force Analysis application was
developed. Additional US Patents were applied for and received. We are currently
registered with the FDA for the Gait Analysis System and the Pressure Pro insert.
The insert is reimbursed under Medicare Part B Therapeutic Shoe Bill coverage as the
A-5513 custom insert.

The US Patents, mentioned above, cover plantar foot pressure measurement technology,
foot orthotic fabrication on the basis of peek in-shoe pressure determination and gait
force analysis post fit to confirm if the harmful peak pressures (both vertical and shear)
have been reduced to safer levels. During a 2 year pilot study using the AcuStep
technology in California no foot ulcers recurred in this limited but high risk sampling of
10 patients with recently healed insensate foot ulcers. Normally, the foot ulcer
recurrence rate in the best programs for patients with diabetes and high risk
insensate feet is 22%. Without good management, the recurrence rate jumps to over 76%.

Scope of Practice: The AcuStep Foot Center has an adjoining Diabetic Foot Center
facility to take advantage of dramatic technological developments in the area of foot
sensor technology and pressure analysis. Our initial Foot Center opened mid November,
2009 in Springfield, MO. The AcuStep Diabetic Foot Center, LLC (“DFC”) will provide
preventive assessment and management of the patient with diabetes, pre-diabetes,
neuropathic patients with “at risk” involvement of the lower limbs and feet, peripheral
arterial disease and other foot problems needing preventive intervention. The DFC
preventive program includes Management, Outreach, Research and Education.
Interventive measures include general management, non-invasive vascular testing for
small and large vessel disease, in-shoe gait force analysis and fitting CMS approved
shoes with peak pressure off-loading inserts. All patients will sign an informed consent
document signifying their understanding that DFC cannot prevent complications such
as ulcers, infections and amputations but it is the goal of DFC to attempt a reduction in
the RATE (risk) of such complications. The program is protocol driven based on current
information in the academic peer reviewed literature. Any patient who develops a
complication will be referred to their referring physician for treatment. Next Spring,
a level I Randomized Clinical Trial will be initiated for qualifying Medicare diabetic
patients to evaluate footwear and orthotics currently authorized under the Medicare
Therapeutic Shoe Bill program (“TSB”).

Long Term Strategy: What is not generally appreciated by the public and even the
medical community, is the need to determine and monitor in-shoe post fit peak foot
pressures as a requirement for CMS (Medicare) reimbursement within the TSB program.
This is not current CMS policy but it is our policy. It has been estimated that if this one
policy change were implemented, over $1.9 billion could be saved annually by CMS in the
cost of care of the diabetic foot and its complications. This is analogous to trying to
manage the hypertensive patient without determining blood pressures or diabetes
without determining key metabolic markers such as fasting blood glucose determinations.
It is simply not effective. The goal is to change CMS policy – to dramatically improve the
care and outcomes of the patient with diabetes and “at risk” feet based on state-of-
the-art preventive measures.

Mismanagement of peak plantar foot pressures is not limited to just the patient with
diabetes. Foot comfort and athletic performance are directly and negatively impacted
by this problem as well.

JGF