Perspectives in Circulation Today

A Crisis: Obesity, Diabetes and Its Complications:


Obesity, Over-Nutrition Relevant to Activity

Figure 1 showing increasing mortality with incr-
eases in BMI. Should 30 be a definition of obesity?
See www.circulatorboot.com/literature/clotting.html

Figure 2: The American Obesity Epidemic


The Epidemic of Diabetes and its Complications
Figure 3: Prevalence of Diabetes Number (in Millions) of Persons with Diagnosed Diabetes, United States, 1980-2004. Diabetes is becoming more common in the United States. From 1980 through 2004, the number of Americans with diabetes more than doubled (from 5.8 million to 14.7 million). People aged 65 years or older account for almost 40% of the population with diabetes. Between 1996 and 1997 an unusually large increase occurred in the number of people with diagnosed diabetes. Part of this increase is likely due to changes in the survey used to measure diagnosed diabetes (National Diabetes Surveillance System - graph and data). Total costs (direct and indirect): $132 billion - Direct medical costs: $92 billion - Indirect costs: $40 billion (disability, work loss, premature mortality)(Estimates for 2002 American Diabetes Association). About 15% of diabetics will suffer leg/foot wounds during their lifetime. More than 60% of nontraumatic lower-limb amputations occur among people with diabetes. In 2000-2001, about 82,000 nontraumatic lower-limb amputations were performed annually among people with diabetes.

Figure 4:In 2002, the rate of hospital discharge for nontraumatic lower extremity amputation (LEA) per 1,000 persons with diabetes increased with age for all levels of amputation. The largest relative and absolute increase in level of LEA across age groups occurred for above knee LEA. The above knee LEA rate per 1,000 persons with diabetes increased from 0.5 among persons less than 65 years to 3.4 among persons aged 75 years and older. LEA rates by level also varied within the three age groups. Among persons with diabetes aged less than 75 years, the rate of toe LEAs was greater than other levels, while among persons aged 75 and older, toe, below knee, and above knee LEA rates were similar. (National Diabetes Surveillance System)

Figure 5: Number (in Thousands) of Hospital Discharges with Peripheral Arterial Disease (PAD), Ulcer/Inflammation/Infection (ULCER), or Neuropathy as First-Listed Diagnosis and Diabetes as Any-Listed Diagnosis, United States, 1980-2002 PAD, ULCER, and neuropathy are costly and disabling conditions that can lead to lower extremity amputation. From 1980 through 2002, trends in the number of hospital discharges for these conditions as the first-listed diagnosis varied by condition. During the 1980s, the number of discharges for PAD and ULCER increased, and discharges for neuropathy decreased. However, in the 1990s through 2002, discharges increased for ULCER and neuropathy. For PAD, discharges increased until 1997 and then decreased thereafter. In 2002, there were about 93,000 discharges for PAD, 100,000 discharges for ULCER, and 58,000 discharges for neuropathy. (National Diabetes Surveillance System)

Prevalence of Diabetes Throughout the World

(Figures are in the thousands.)

<<<<<<<<<-------------------Type 1 Diabetes---------------------> <--------------------Type 2 Diabetes------------------>

Region 1995 1997 2000 2010 1995 1997 2000 2010
Americas
1187.8 1194.7 1407.9 1654.0 24191.5 25309.6 28350.9 38472.4
North America
879.2 885.0 1018.7 1174.8 12097.6 12462.9 13174.0 16360.2
Asia
1030.1 1039.8 1608.3 2241.0 61751.7 65008.2 82901.9 138056.1
Africa
84.7 85.3 142.1 219.4 7208.9 7644.2 9239.7 13933.0
Europe
1154.8 1141.9 1181.7 1244.9 20885.2 21156.7 25325.2 31620.4
Oceania
80.7 81.7 83.0 87 839.7 875.2 955.6 1241.0
Amos AF, McCarthy DJ, Zimmet P: The Rising Global Burden of Diabetes and Its Complications: Estimates and Projections to the Year 2010. Diabetes Medicine 17:S7-S85, 1997

Who can be helped?

The combination of aging and the burden of obesity and diabetes has the potential to financial ruin any private of governmental health insurance system. It is questionable that the resources will be available to offer all diabetics with foot problems the option of inpatient care and invasive revascularization procedures. It is the belief of the Circulator Boot Corporation that outpatient boot care provided appropriately in time can avoid many of these costs. While decisions for the care of individual patients should remain in the hands of the attending physicians, remuneration policies of the insurance industry can and do affect physician choices. It is to be appreciated that FDA approval of a new procedure, catheter or pneumatic boot does not override the judgment of a physician in the care of the individual patient. Nor do the dictates of the FDA limit the physician from considering off-label indications for treatments. Below are listed FDA approved indications for Circulator Boot therapy and below that off-label and potential research indications.


Indications listed in our manual as allowed by the FDA include:

Poor arterial flow in the leg associated with:
Ischemic ulcers
Rest pain or claudication (pain with walking)
Threatened gangrene
Insufficient blood supply at an amputation site
Persisting ischemia after embolectomy or bypass surgery
Pre and Post-arterial reconstruction to improve runoff
Diabetes complicated by the above or other conditions possibly related to arterial insufficiency:
Nocturnal leg cramps
Necrobiosis diabeticorum
Venous diseases (once risk of emboli minimized):
Prophylaxis of deep vein thrombophlebitis
Edema and induration associated with chronic venous stasis
Venous stasis ulcers
Lymphedema:
Recent (therapy is most effectively initiated before secondary fibrosis has become established)
Chronic
Congestive heart Failure

Off-Label Indications for Circulator Boot Therapy that have been associated with success in anecdotal cases and might be considered for research projects:

Poor arterial flow in the leg/hand associated with or due to:
Traumatic injury
Status post repair of arteries after trauma
Burns
Frostbite
Buerger's disease
Diabetic neuritis (painful)
Complications of Chemotherapy
Diabetes complicated by problems outsides the extremities(See www.circulatorboot.com/casehistory/csemenu1.html):
Renal failure
Retinal edema/hemorrhage
Other Cardiovascular Problems
Angina and Acute Myocardial Infarction
Stroke
Arteriosclerotic Cardiomyopathy
Septic shock
Conversion of New Atrial Fibrillation
Acute Cardiac Dilatation
Erectile dysfunction (penile boot attachment)

Perspectives in Circulation Today

Volume 2, Number 4

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