John F. Boyle DPM
1130 Western Avenue
P.O. Box 6040
Chillicothe, OH 45601
740-775-7800
June 14, 2000
Mr. David Plank
Circulator Boot Corp.
72 Pennsylvania Avenue
Malvern, PA. 19355
Re: EFFICACY OF END DIASTOLIC PNEUMATIC COMPRESSION THERAPY
Dear Mr. Plank:
This is a letter to update you on the success that we have found using End Diastolic Pneumatic Compression for diabetic foot ulcers. It is my pleasure to inform you that I have seen significant improvement and healing of wounds otherwise regarded as a lost cause. These patients would have eventually gone on to below knee amputation which as you know costs Medicare between fifty and sixty thousand dollars per amputation. I have been using End Diastolic Pneumatic Compression now for approximately five months and in that time we have successfully healed at least six individual patients with significant ulcerations of their feet.
One gentlemen in particular who already suffered a BKA of his right limb had an exceptionally large ulceration and went on to bypass surgery with an improvement of AVI index of .2-.6. His ulcer was stagnant and not healing for a period of three months after bypass surgery. We placed him in End Diastolic Pneumatic Boot Compression Therapy and have documented an increase of his AVI to .85 from .60. This is approximately a 25% increase in the blood flow after only eight treatments of End Diastolic Pneumatic Compression. His ulcer is now almost completely healed. I have several other case studies I will forward to you as soon as time allows. I cannot thank you enough for this particular advanced technology in limb salvage.
As you know, for every limb that we salvage we have saved Medicare and insurance carriers anywhere between fifty and sixty thousand dollars per occurrence. Here in my area approximately between 1997 and 1998 there were approximately 100 amputations per year. If we are able to save even half of those from going on to amputation that would have saved Medicare in the neighborhood of 2.5 million dollars. In my opinion not only is End Diastolic Pneumatic Compression effective in limb salvage but it is extremely cost effective.
Thanks again for making this technology available.
Sincerely,
(Original signed) John F. Boyle, D.P.M.
Appreciative Patient
The following is a letter received
from a patient in Virginia.
She was treated by Marc Blatstein, DPM Fredericksburg, VA Phone:
540-785-4335
Dear Mr. Makowski:
Since 2002 I have had a total of four surgeries on my right leg and one surgery on my left leg because the blood was not flowing through the arteries to the leg. In January, May and September of 2003 I underwent surgeries to the arteries in my right leg. Upon completion of the last surgery in September the surgeon stated that the main three arteries were no longer functional and that additional surgeries on the arteries would not be a course of action. Amputation of the leg was the next step if the flow of blood could not be maintained through the collateral blood flow. At that time, I would wake up multiple times during the night with severe pain in my right leg and foot. I could not walk more that 50 feet without requiring rest. I would also have severe pain in my foot when at rest while awake.
I began receiving Circulator Boot Therapy in November 2003 five days a week for two months, 2 times a week for two months, and currently once a week. Since starting the Circulator Boot Therapy, I no longer wake up during the night with severe pain in my leg and foot, I am able to walk up to 250 feet without requiring rest, and most important to me I have not required any kind of surgery in the past nine months. My vascular surgeon has recommended that I continue with the Circulator Boot Therapy.
I firmly believe had I not began the Circulator Boot Therapy my condition would have continued to deteriorate and in all probability I would have had to have my leg amputated.
Sincerely,
Margaret Cross
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.