Seattle

Therapeutic footwear does not necessarily benefit diabetics with sensitive feet, according to a study published last month in the Journal of the American Medical Association.

The two-year study, which followed 400 Washington-area diabetes patients with a history of foot ulcers — mainly men ages 45 to 84 years, from the Veterans Affairs Puget Sound Health Care System — divided the patients into three groups. One group wore therapeutic shoes containing customized, medium-density cork inserts with a neoprene closed-cell cover. Another group wore therapeutic shoes containing prefabricated, tapered polyurethane inserts with a brushed nylon cover; and a third group wore “their usual footwear,” the article explained. All three groups received “careful attention to foot care” from health care professionals, and none of the participants had severe foot deformities.

At the end of two years, researchers found that while the overall rate of reulceration was low — 15 percent in the cork-insert group, 14 percent in the prefabricated-insert group and 17 percent in the control group — “patients assigned to therapeutic shoes did not have a significantly lower risk of reulceration [than did patients in the control group].”

Moreover, the level of medical care that patients received seemed to influence foot health more than did the type of footwear the patients wore, the researchers said. But these findings “do not negate the possibility that special footwear is beneficial in persons with diabetes who do not receive such close attention to foot care by their health care providers, or in individuals with severe foot deformities,” the researchers added.

These results raised questions and a few eyebrows among pedorthists, therapeutic-footwear manufacturers and other podiatric researchers.

Jim Foto, a biomedical research engineer and pedorthist at the Baton Rouge, La.-based National Hansen's Disease Program, wondered why the study's authors did not explain the meaning of “usual footwear.”

“There is no description of the control group's footwear,” he said. “In many instances, a person's own footwear is the best condition.”

Often, patients with diseases like diabetes — diseases that can cause a loss of protective sensation in the feet, called neuropathy — already wear softer, less damaging shoes, which could be considered therapeutic, Foto explained. Consequently, this study's authors may be comparing oranges to oranges.

Additionally, the fact that none of the study's participants had foot deformities is significant, Foto said.

“In our research, we see a more radical change when there is foot deformity, as opposed to no foot deformity,” he added.

Russell Volpe, medical director to the Deer Park, N.Y.-based manufacturer Langer Biomechanics Group, wondered why the VA researchers chose to study cork and polyurethane inserts rather than the widely used “plastazote” substance that many in the therapeutic-footwear industry have accepted as the standard of care.

While not commenting directly on the VA study, Bob Fox, vice president of sales and marketing at Atlantic Footcare in North Smithfield, R.I., pointed to a 1997 study conducted at the University of Texas in San Antonio, which concluded that therapeutic shoes and insoles are beneficial to foot ulcer-prone diabetes patients. The Texas study used insoles manufactured by Atlantic Footwear, and “prompted us to get into the [therapeutic footwear] business,” Fox said.

Ultimately, no single study can be 100 percent conclusive, Foto said. While the VA study draws some interesting conclusions, it also raises further questions.

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