Ontario High Intensity Diabetic Foot Treatment Initiative

Phase I – Pilot Project

1. Type of Improvement: New Service

2. Capital Requirement: None

3. Population Served: Persons with diabetes that develop complications

4. Problem / Need Description

5. Cost to Healthcare

Foot 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 is poor.

The 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.

In 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 expenses.

6. Proposed Approach

Many healthcare practitioners are aware of existing therapeutic technologies which can be utilized to effectively treat and cure diabetic foot ulcers to produce healing and ambulation. The central modality is the Circulator Boot™ which uses the technique of end-diastolic compression.

This technology meets the following tests for suitability in publicly-funded health care:

1. Efficacy and best practice
2. Safety
3. Cost-effectiveness, efficiency and sustainability
4. Improved outcomes
5. Coordination of care

A discussion of the efficacy of this equipment is given in Appendix A.

The 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 B . Abstracts of published studies are given in Appendix C.

Technology is absolutely fundamental to controlling costs. This initiative identifies and addresses a gap in the healthcare system. It involves providing a new service.

It 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 ulcers.

It aligns with a Ministry of Health direction of providing improved outcomes where possible, and avoiding the ongoing costs of long-term disability.

It 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.

7. Patient Selection

Most 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 initiative.

Skin perfusion pressure testing and other diagnostics are used to determine the extent of arterial limb ischemia and to monitor progress.

To 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 2:

- Wagner Grade 1 Superficial diabetic ulcer, or
- Wagner Grade 2 Deep ulcer involving a ligament, joint capsule or facia

8. Health Care Provider (HCP)

Rather 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:

To determine a particular clinic's suitability for inclusion, a set of objective selection criteria has been established. These are listed in Appendix D.

Clinics 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.

Proposed Locations

1. Windsor
2. London
3. Cambridge
4. Hamilton
5. Brampton
6. Mississauga
7. Toronto
8. Richmond Hill
9. Oshawa
10. Kingston
11. Ottawa
12. Barrie
13. Sudbury
14. Thunder Bay

9. Treatment Description

Patients arrive at the clinic at one-hour intervals with the treatment lasting 40 minutes. The Circulator Boot 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.

For 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.

Foot ulcers can also affect the non diabetic population where the condition can be brought on by stroke or vascular disease.

Where blood supply is adequate and tissues are not infected, electrotherapy by means of a galvanic stimulator accelerates wound healing. TENS and ultrasound are used to stimulate the area and further enhance healing.

Ultrasonic debridement is used to remove eschar with minimal damage to viable tissue. Where surface infection is problematic and refractory to treatment, ultraviolet-C radiation provides bacteria eradication.

10. Benefits

This initiative enhances the patient's health care experience, provides improved outcomes and is financially justified by reducing hospitalization.

The 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.

Positive 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.

After 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.

There 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.

11. Description

This new service is provided by adding the treatment to the scope of an existing out-patient clinic.

12. Communications

Coordination 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 disease progression.

13. Estimated Implementation Timeframe

To properly evaluate the benefits from this new service, it will be implemented in phases at each location..

Phase I)

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, or discontinued.

Phase II)

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.

Milestones

14. Project Cost Projections for Phase I at each site

Cost per patient, for treating 20 patients = $3,300

15. Cost Alternatives Analysis

Without 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.

A low risk investment of $67,400 produces cost-avoidance of $176,000 in the first year.

Appendix A   Circulator Boot Efficacy and Effectiveness in Clinical Practice
Appendix B   Summary - Clinical Research Studies
Appendix C   Published Clincal References – End Diastolic Compression
Appendix D   Facility Readiness for Circulator Boot Therapy

This proposal outline has been prepared and presented by:
Dave Hanneson
BIOMATION
335 Perth Street, P.O. Box 156
Almonte, ON K0A 1A0

E-mail: dh@biomation.com

February 6, 2013

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