Foot clinic reduces the referral rate for amputation to zero

Jacksonville Foot Health Center

Earl R. Horowitz, DPM
Podiatrist-Foot Specialist
(904) 387-0433

June 13, 2000

To Whom It May Concern:

Re: The use of the Circulator Boot for the treatment of diabetic foot and leg pathology.

Diabetic lower extremity complications are a major tragedy to the patient, as well as having exceptional economic effects on insurance and federal reimbursement plans.

I was the director of the Diabetic Foot Clinic at the city hospital in Jacksonville (University Hospital) for ten years. We saw 35-40 patients at each clinic session. During this time we were able to reduce major lower extremity amputations. The government in its wisdom during the last few years has instituted with the passing of the Diabetic Foot and Shoe act, a method of patients being correctly fitted with shoes that relieve pressures that has aided in controlling many of the complications of the diabetic. New wound centers have developed utilizing growth factor treatments, hyperbaric oxygen, multidiscipline medical specialist utilizing their expertise in treatment programs. Home nursing care has emerged specializing in wound dressing changes. Bypass arterial surgery has more than doubled the last few years as a means of lowering the amputation rate. It is still a fact that with all these innovations 70,000 leg amputations are performed each year, which is actually an increase over the last 10 years. Lower extremity infections and complications are the most common cause of hospitalization for diabetes. We have also seen a dramatic increase in cost factors.

Three or four years ago I opened the Diabetic Foot/Wound Center to try to lower diabetic complications and the amputation rates in the lower extremity. We were entering patients into the hospital with infections and ulcers. Our amputation rate while lower than the national average was still high.

Two years ago I investigated and started to use the Circulator Boot, which I found to be FDA approved with twenty years of patient treatment results. The Circulator Boot treats circulation problems ranging from micro dysfunction, (arterial and venous shunting) small and large arterial vessel disease and venous pathology. The Circulator Boot controls infections due to the secondary function that includes an enclosed bag system of electrolyte and antibiotic solutions pumped into the wounds.

The Diabetic Foot/Wound Center sees approximately 25 - 30 patients a day, of which 15 - 20 are diabetic ulcer patients. The noninvasive nature of this pumping modality is controlled by the heart. The patient's heart rate controls the number of times the pump goes into action, creating a push of the normal blood supply into the diseased area. We have used this on vessels that are stenotic and conditions that range from small necrotic ulcers to large gangrenous ulcers and gangrenous parts of the foot.

After 2 years of Circulator Boot therapy, surgical and chemical debridements and the use of pressure relief devices, we have not entered a patient into the hospital to amputate a leg or to treat an infectious process in the lower extremity. Normally we would enter 1 or 2 patients a week into the hospital due to infection or circulatory pathology. We have not had to use bypass surgery and on the contrary we have actually opened up arteries that were still closed after bypass surgery was previously performed.

We have had the experience of patients leaving the hospital a day or two before an amputation was to be performed and started Circulatory Boot therapy. These patient's wounds have closed with no major amputation and they are now walking.The use of the Circulator Boot has changed our treatment methods for the care of the diabetic patient with complications in the lower extremity. It has been a great aid to increasing circulation to those patient that don't have ulcers at this time, but due to circulatory dysfunctions tissue breakdown may occur with non-healing consequences. There are patients who have one leg amputated and are worried about losing the other leg, especially where there is a reduction of adequate arterial peripheral circulation. Where bypass surgery has not been the answer or can not be performed this pump has been dramatic in allowing these patients to reduce their pains, increase their circulation and has even aided in the control of some neuropathy type of problems reducing swelling in the legs and feet.

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