Ontario High Intensity Diabetic
Foot Treatment Initiative
I – Pilot Project
Type of Improvement: New Service
Capital Requirement: None
Population Served: Persons with
diabetes that develop complications
Problem / Need Description
foot ulcers, one of the most common complications
of diabetes mellitus, are often recalcitrant to treatment
and are associated with serious medical complications
such as osteomyelitis and lower limb amputation. Around
15 - 20 years after the onset of diabetes, most people
will begin to experience diabetic neuropathy, especially
in the feet and legs. As the condition progresses,
the pain becomes more intense. Eventually the area
loses all sensation, increasing the risk of tissue
injury. The condition is caused by poor blood flow
to the extremities. Ulcers appear when the blood supply
is inadequate to support viable tissue. The condition
progresses in a predictable manner to develop into
infection and gangrene. Amputation, disability, chronic
and decreased quality of life are the inevitable outcomes
when the patient does not receive suitable and timely
treatment at a high intensity clinic.
focus of this initiative is in avoiding hospitalization
for persons with foot ulcers and lessions.
Cost to Healthcare
problems are the most common reason for hospitalization
among diabetics. Costs further escalate when amputation
is needed. For someone with already poor ambulation,
an amputation is disastrous. The 5-year survival rate
amputation rate for diabetics is currently 15 –
20 per year per 100,000 of the general population. In
a catchment area of 500,000 population, and with a typical
total cost of $35,000 per case, the cost to the public
healthcare system is $2.6 – 3.5 million annually.
These costs are avoidable with appropriate treatment.
addition, the patient becomes disabled with a poor quality
of life. The patient faces high unavoidable costs from
lost income, transportation expenses and increased living
healthcare practitioners are aware of existing therapeutic
which can be utilized to effectively treat and cure
diabetic foot ulcers to produce healing and ambulation.
The central modality is the Circulator
which uses the technique of end-diastolic compression.
technology meets the following tests for suitability
in publicly-funded health care:
1. Efficacy and best practice
3. Cost-effectiveness, efficiency and sustainability
4. Improved outcomes
Coordination of care
discussion of the efficacy of this equipment is given
therapeutic technique has been well documented and in
successful use for more than 20 years. The treatment
process is well understood. A summary of the clinical
references and quality of evidence is given in Appendix
Abstracts of published studies are given in Appendix
is absolutely fundamental to controlling costs. This
initiative identifies and addresses a gap in the healthcare
system. It involves providing a new service.
aligns with an important healthcare focus area by addressing
the escalating cost of diabetes and supports the implementation
of Ontario's diabetes strategy. It meets the strategic
objective of improved access to critical services for
patients with chronic conditions such as diabetic foot
aligns with a Ministry of Health direction of providing
improved outcomes where possible, and avoiding the ongoing
costs of long-term disability.
is long-term sustainable because it avoids costs by
reducing hospitalization expense. The cost reductions
are far in excess of the cost of running the program.
The patient regains mobility and independence.
cases of amputation begin with only a minor injury to
the foot or leg. Nearly all cases of severe ulceration,
gangrene and infection that are grounds for amputation
begin as non-healing ulcers and lesions. The severity
of these is classified as Wagner Grade 1 for a superficial
ulcer through to Wagner Grade 3 for deep ulcers with
cellulitis, abscess formation and osteomyelitis and
Grade 4 for gangrene in the toes or forefoot. Most patients
with ulcers up to Grade 4 can be successfully treated
and healed, but the Grade 3 and 4 ulcers do require
a longer course of treatment. Pain during treatment
can be problematic. Chronic Grade 1 and 2 ulcers respond
more quickly to treatment and are the focus of this
perfusion pressure testing and other diagnostics are
used to determine the extent of arterial limb ischemia
and to monitor progress.
qualify for this initiative, patients would be expected
to have reasonable expectation of full ambulation after
successful healing. Deep vein thrombosis is a contraindication.
Patients will be either diabetic or non diabetic and
have chronic ulcers or lesions in the feet or legs that
have not shown any healing progress in the previous
30 days. The ulcers can be either infected or not, either
ischemic or not. The severity level can be up to Grade
- Wagner Grade 1 Superficial
diabetic ulcer, or
- Wagner Grade 2 Deep ulcer involving a ligament, joint
capsule or facia
Health Care Provider (HCP)
than attempt to start a single-purpose clinic, several
delivery models of HCP will be evaluated to determine
the best synergy for providing intensive diabetic foot
treatment as part of an existing clinic:
Hospital ambulatory clinic
Physician-run wound clinic
Kidney dialysis unit
meeting acceptance criteria already attend regularly
HBO wound clinic
determine a particular clinic's suitability for inclusion,
a set of objective selection criteria has been established.
These are listed in Appendix
with suitable facilities and suitably trained staff
exist in each of the 14 proposed urban locations. These
are aligned with each of the 14 LHIN's.
8. Richmond Hill
14. Thunder Bay
arrive at the clinic at one-hour intervals with the
treatment lasting 40 minutes. The Circulator
uses air pressure to provide a continuous series of
short-duration compression pulses to the foot and leg.
The compression pulses are timed to occur between heart
beats. This produces an immediate boost to arterial
and venous circulation and slowly breaks down clots.
The resulting increased blood flow brings oxygen and
nourishing metabolites to the affected tissues. It removes
waste products and excess fluid. Systemic antibiotics
are circulated to infected tissues.
cases of cellulitis, locally injected antibiotics can
be infused through the affected tissues. A soak of essential
electrolytes can be provided to further enhance healing.
A series of 20 treatments is expected to produce healing
of a superficial ulcer in most cases.
ulcers can also affect the non diabetic population where
the condition can be brought on by stroke or vascular
blood supply is adequate and tissues are not infected,
electrotherapy by means of a galvanic
accelerates wound healing. TENS
and ultrasound are used to stimulate the area and further
debridement is used to remove eschar with minimal damage
to viable tissue. Where surface infection is problematic
and refractory to treatment, ultraviolet-C
provides bacteria eradication.
initiative enhances the patient's health care experience,
provides improved outcomes and is financially justified
by reducing hospitalization.
proposed approach produces a positive impact on the
local health system. It meets the three objectives of
the healthcare improvement framework
- Improves the health of the diabetic population;
- Enhances the patient care experience; and
- Reduces the per capita cost of care.
outcomes, with significant improvement or complete healing,
are expected in 85% of cases, based on the experience
of clinics using these techneiques. The non response
in the remaining 15% of cases is usually attributed
to an unavoidable comorbidity such as kidney disease
or cardiac arrhythmia.
successful healing, the patient will be instructed to
maintain a healthy active lifestyle with regular walking,
better diet, weight loss and keeping better control
of blood glucose levels. Regular followup will evaluate
compliance and ensure a durable positive outcome.
is significant financial benefit to the healthcare system.
By avoiding hospitalization expenses, the project is
expected to produce a net financial savings, even within
the first year of implementation. A key performance
indicator that benefits from this initiative is the
percent of hospitalizations for persons with diabetes.
new service is provided by adding the treatment to the
scope of an existing out-patient clinic.
with local health care providers is essential. During
the first two weeks of operation, staff will compile
a list of potential referral sources. These will include
physicians, diabetes clinics, community nurses, vascular
centres and kidney dialysis units that are a potential
source of new patients. A brochure describing the new
services will be prepared and distributed. It is recognized
that, for this new service to be effective, it will
be necessary to identify potential cases early in the
Estimated Implementation Timeframe
properly evaluate the benefits from this new service,
it will be implemented in phases at each location..
Pilot project of 24 patients treated during 12 months.
To enhance flexibility, most of the needed equipment
will be leased for the one-year period. One new case
will be accepted approximately every two weeks. It is
anticipated that each new case will require about 20
– 30 treatments of 40 minutes each. The duration
of treatment is a maximum of eight weeks at which time
the outcome will be evaluated. The clinic caseload is
two to three treatments per day. After completing treatment
for the first 20 patients, all of the outcomes will
be tabulated and a report issued. The report will evaluate
costs and outcomes on objective criteria and make recommendations
for any changes or corrective action to continually
improve performance. The report will recommend that
the service be either expanded, continued as-is, modified,
Expand the project to treat 50 patients per year to
enhance the service and to increase hospitalization
expense avoidance. The clinic will handle one new case
per week at a caseload of about five treatments per
day. Consider widening the admission criteria to include
Grade 3 and 4 ulcers, bilateral treatment and acute
cellulitis. This will require the addition of diagnostic
equipment, including skin perfusion pressure testing,
if not already available, purchasing the therapeutic
equipment and expanding the staff to one full position.
recruited and trained
patients complete treatment
patient completes treatment
I of project closed
14. Project Cost Projections for
Phase I at each site
portable electrical stimulators
Including compression bags, electrodes, electrolyte
soak, electrodes, injectables
staff, ½ position
management and expert consultation
to visit other clinics
project cost for 12 months
Cost per patient, for treating
20 patients = $3,300
Cost Alternatives Analysis
treatment, this patient group will require hospitalization
for life-threatening infection and gangrene. Symptoms
often worsten slowly over a few years, with about 50%
requiring hospitalization within one year and the remainder
within 2 – 3 years.
of patients require hospitalization
– 10 patients x $35,000
high intensity diabetic foot treatment clinic
– Cost of Phase I implementation
patients require hospitalization – 3 patients
costs avoided in year-one by undertaking this
low risk investment of $67,400 produces cost-avoidance
of $176,000 in the first year.
proposal outline has been prepared and presented by:
335 Perth Street, P.O. Box 156
Almonte, ON K0A 1A0
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