Some Important Facts & Statistics

1. In 1990, the average cost per lower extremity amputation was $57,300, our average cost of treatment is $5000-6,000 and it results in saving patients leg.
2. Every year, 7 or 8 of every 1000 Americans who have diabetes undergo amputation of the foot. This is twice as high in African Americans and higher in Hispanic and Native Americans (Postgrad Med. July 1999). Rates increase with age and duration of the disease.
3. Foot infections account for 25% of all hospital admissions of diabetic patients.
4.When foot ulcers develop one in five of these patients undergo amputation.
5. Approach with knowledge of risk factors and multidisciplinary team can prevent up to 85% of these amputations.
6. Ischemia is the only factor that, in itself, can necessitate foot amputation.
7. The choices are: vasodilating drugs, bypass graft surgery, hyperbaric oxygen and most effective: Circulator boot therapy.
8. Vella studies (J Vase Med 2000; 5(1);21-5) 29 pt's with transcutaneous Oxygen tension below 20 mmHg at the ulcer site - 19 had favorable outcome. Wound healed completely, ulcer decreased in size.
9. Prevalence of PAD 3 % age 40-59, 8% age 60-69, 19% over age 70. In US 8.4 million individuals. It is a marker for systemic atherosclerosis and CV risk. Causes pain when walking, fatigue or discomfort. Lowers quality of life.
10. Significant new research - Dr. Michael Gimbrone (Vascular Research Division at Brigham and Women's Hospital and Harvard Medical School in Boston) studied global patterns of gene expression in cultured human umbilical vein endothelial cells HINBC exposed to laminar shear stress and turbulent shear stress (LSS and TSS). Studies documented in vitro that endothelial cells can differentially sense and transducer different input stimuli, EC can produce potent mediators: VEGF, coagulationl/fibrynolytic factors, cytokines, prostaglandins, and EDRF such as nitric oxide. Distinct patterns of EC gene expression: "vaso-protective."
11. 50% of pt’s in 5 years with IC are stable or get better. 16% have progression of disease and 25 % will require surgery of experience tissue loss.
12. Description of device: it is an equipment system designed to compress chosen portions of the leg during specific time in a cycle of the heart, during the relaxation phase. It uses pressurized air for external compressions. It is applied in a series of treatments lasting for 40 min each. Typically 35 trea1ments may be required.
13. Who can benefit: Our patients usually are the toughest, most difficult to treat. Many often had significant leg ulcers or gangrene, and are referred to us since nobody can help them. They are about to undergo leg amputation.
14. We treat patients with arterial plaques, who 14. We treat patients with arterial plaques, who either have leg pain while walking or at rest, patients with complications of lack of oxygen supply to the leg leading to skin and surrounding tissue damage, ulcers, infection and bone infection. Many patients have diabetes mellitus, are former cigarettes smokers or have kidney disease and are on dialysis. Less common we see leg ulcers due to veins occlusion or patients with significant leg swelling from different causes.
15. The treatment is: Safe, painless, approved by FDA, covered by Medicare and many insurances, non-invasive, and non-surgical. It is proven to be effective in healing infection, restoring leg integrity and function, relieving symptoms of leg pain and fatigue. It eliminates leg swelling. It restores normal sensation in patients with leg's nerves damage - so called neuropathy. Effects of treatment are long lasting.
16. Who qualifies for treatment? Anyone with circulation problems in legs, symptoms of leg pain with walking or at rest, easy fatigability, leg infections, leg ulcers, anyone who was told to have leg or foot amputation. Patients with serious vein problems resulting in leg discoloration, increased leg thickness, and swelling. Anyone with the limited ability to walk because of the leg pain needs tests to evaluate the integrity of circulation, and if they have a problem. They could benefit from the treatment with Circulator boot.
17. What's new about it?
• New research proving effectiveness - Mayo Clinic - Dr. Rooke
• New research explaining how it can open closed arteries especially in small blood vessels, which could be closed from diabetes, blood clots or constricted from hardening of arteries.
• Our observation that infected bones do not need to be amputated, but they can be treated effectively and have their function restored.
• Our observation that we are not competition to vascular surgery, but we work with them as a team, and because our close evaluation of patients and treatment, we can help the patients to get well enough to be a candidate for surgical bypass graft and not for amputation.
18. Our patients have 2% rate of amputations comparing with 30% of patients with a similar degree of leg infection and damage.

"Circulator Boot therapy is associated with improved outcomes in limb ulceration due to peripheral vascular disease." Safe... Congestive Heart Failure is not a contraindication This 60 year-old diabetic male had a right iliac endarterectomy and an occluded femoropopliteal bypass. His rest pain in the right calf and congestive heart failure (top photo) were not responding to usual treatments. Left leg pumping assisted in his heart successfully relieving his heart failure (bottom photo). Right leg pumping relieved rest pain and restored the absent Doppler signal and blood pressure in his posterior tibial artery to 75mm Hg over 9 days. After 6 weeks of out-patient treatments, the ankle pressure was over 200mm Hg in both the anterior and he could walk several blocks. Indications: •Peripheral Arterial Insufficiency • Ischemic Ulcers • Rest Pain • Claudication • Venous Stasis • Lymphedema • Diabetic Foot Warning: Contraindications: 1. Deep venous thrombosis Caution: Federal law restricts this device to sale by or on order of a physician. "Complete ulcer healing as well as preservation of the affectected limb can be achieved in most cases." Before After   Infection & Osteomyelitis Arteriosclerotic & Venous Ulcers Ischemic Necrosis Lymphedema Circulator Boot System * Mini Boot * Long Boot Air * Compressor Heat * Monitor Compression * Valve * Sea Soaks 1. Vascular Medicine 2000; 5:21-25; Circulator boot therapy alters the natural history of ischemic limb ulceration. Vella A., Carlson L, Blier B, Felty C, Kuliper JD, and Rooke TW. 2. Advances in Heart Disease, Vol.1, Edited by D.T. Mason, Grune & Stratton, New York, 1977. Noninvasive circulatory assistance by external counterpulsation. 3. Angiology 31:614-638, 1980. Effective therapy with pneumatic end-diastolic leg compression boot on peripheral vascular tests on clinical course of peripheral vascular disease. 4. Angiology 37: 47-56, 1988. Treatment of resistant, venous stasis, ulcers and dermatitus with end-diastolic pneumatic compression boot. 5. Ann Surg 204: 643-649, 1986. Successful treatment of osteomyelitis and soft tissue infections in ischemic diabetic legs by local antibiotic injections and the end-diastolic pneumatic compression boot. 6. J.Clin Engineering 5: 63-66, 1980. An end-diastolic air compression boot for circulation augmentation. 7. VASC Surg (Westerminister Press) 24:682-695, 1990. Treatment of osteomyelitis in diabotic foot with systemic and locally-injected antibiotics and the end-diastolic pneumatic compression boot - case studies. 8. Angiology 47: 123-129, 1996. Optimizing external cardiac-assist compressions in patients with atrial fibrillation by anticipating the next beat.