Diabetes does not require an introduction. This metabolic disorder in which the body either does not produce insulin or does not properly use the insulin to breakdown the sugar in the blood, has been known to the human civilization as early as the ancient Greeks. The word "diabetes” in ancient Greek literally meant "siphon” to denote the symptoms of frequent urination exhibited by these patients. Diabetes is a systemic disorder that can lead to heart disease, stroke, neuropathy, poor circulation leading to amputation, hearing loss and vision problems. This article specifically explores the cause, effect, treatments and prevention of foot disorders in diabetic patients.

In the U.S. and rest of the world, statistics show that diabetes is stealthily growing to epidemic proportions. The American Diabetes Association estimates that there were 18.2 million diabetic patients in the U.S. in 2002. This has grown by 61 percent from 1991 and is expected to double by 2050. Half the diabetics are either 55 years or older. It has been estimated that fighting diabetes costs the U.S. economy $ 132 billion annually. More than 25 percent of the Medicare expenditure is towards treating diabetes.


Although the exact mechanism is not known, high levels of blood sugar seem to lead to degeneration of the peripheral nervous system. This degeneration is called neuropathy and makes the feet insensitive to heat, cold and pain. Also diabetes causes clogging of the peripheral arteries leading to poor circulation. The combination of neuropathy and poor circulation cause even scrapes, cuts, bruises and calluses of the feet to develop into major health problems. Due to the neuropathy, the patient does not feel the pain from these simple injuries and neglects them. The poor circulation prevents proper healing of these wounds, which could fester, develop gangrene and may ultimately require amputation. Foot problems constitute about 20 percent of the diabetic hospitalizations. The economic cost of treating a new foot ulcer in a diabetic patient costs $ 28,000 over two years. The risk of leg amputation is about 15 to 40 times greater for a diabetic. In the U.S., every year, at least 60,000 diabetics loose their leg or foot to amputation.

In 1987, Medicare realized that through preventive care, amputations of the lower limbs in diabetics could be reduced significantly. Medicare instituted a trial program in the states of Texas, California, New York, Florida and Illinois of providing diabetic patients vulnerable to foot ulcers with one pair of therapeutic shoes every year. This program later was rolled out to other states in 1993 and is commonly referred as "Therapeutic Shoe Bill”.

This beneficiaries of this Medicare program should be treated for diabetes and also should meet one or more of the following conditions:

• Peripheral neuropathy with the evidence of callus formation

• Previous diagnoses of pre-ulcerative calluses

• Previous diagnoses of foot ulceration

• Foot deformity

• Previous amputation of a foot or part of a foot

• Poor circulation

The patients need a prescription from a physician to avail of this benefit. Medicare payments for such shoes could range from $129 for a pair of off-the-shelf depth shoes to $374 for a pair of custom-molded shoes for patients with foot deformity.

This Medicare policy has jump started the orthopedic/therapeutic footwear industry in the U.S. The total revenue generated by this industry was estimated to be $216.4 million in 2003 and is expected to grow at an annual rate of 31 percent.

The major players in this industry have decades of experience in this profession. Some of the larger organizations are:

1. APEX Foot Health Industries, Teaneck, NJ: This organization has been making therapeutic footwear since 1946. Considered market leader in off-the-shelf therapeutic foot care products, APEX does not deal in custom-molded footwear.

2. P.W.Minor, Batavia, NY: This organization has been in the therapeutic footwear business since 1867.

3. Acor, Cleveland, OH: This is a relatively newer player in the market having been established in 1973. Acor is a renowned name in the market for both off-the-shelf depth shoes and custom-molded shoes. It also features a vast line of therapeutic inserts.

4. Tru-Mold, Buffalo, NY: This is the market leader in custom molded shoes.

5. Prime Materials Corporation, Batavia, NY: This has been set up as a joint venture between P.W.Minor and Produvarios Inc. of Cali, Columbia. Prime Materials Corporation produces the "Treadeasy” line of therapeutic inserts.

Although the prospects for this industry looks rosy due to the burgeoning diabetic population in the U.S., the prescription orthopedic footwear market has its share of challenges, too. Medicare holds the key to this market. Any curtailment or roll back of the Medicare's Therapeutic Shoe Bill could negatively affect this industry. Medicare also sets the prices for the products, constraining the manufacturers. Newcomers to the market also need to develop strategies to compete with the well-entrenched players in this market. Abuse of the Medicare policies even by a few players, could cast the whole industry in a bad light in the eyes of Medicare.

It is hoped that the all the players in this market, namely, medical professionals, patients, manufacturers and payors, will play by the rules so that foot health of the diabetics could be enhanced, and the number of amputations be reduced.

For further information please contact:

Katja Feick
Corporate Communications
+44 (0) 207 915 7856
Katja.Feick@frost.com

www.medicaldevices.frost.com