Standard of Care
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Type 1- Precautionary, safeguard footwear
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Level 1 - Low Risk*
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Are intended
for use in the normal activities of daily living as a platform for prescription in-shoe orthotic products Are not purpose intended
as a platform for customized shoe construction as brace compatible devices as ankle stabilization devices for use as rugged service work shoes for use as uniformed service boots for waterproof applications as oil/solvent resistant footwear as dedicated industrial/commercial, skid resistant, footwear for use as under water mobility footwear for use as performance athletic wear for use as rugged all terrain footwear |
These individuals demonstrate one or both of the following:
(1) Foot deformity or minor foot infection (and a diagnosis of diabetes). (2) Patient education, preventative care and annual brief foot check are required. The patients in this category and the following two categories (Level 2 and Level 3) should not walk barefoot. Special attention is to be directed to shoe style and fit. |
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Type 2- Specialty service and extra duty, pre manufactured and customized footwear
Are intended for
use in the normal activities of daily living use as a platform for customized shoe construction integration in lower extremity orthotic/brace devices use as lower extremity orthotic/brace devices use in the management of venous and arterial insufficiency use as ankle stabilization devices use as rugged service work shoes use as uniformed service boots use in waterproof applications use as oil/solvent resistant footwear use as dedicated industrial/commercial skid resistant footwear use as under water mobility footwear use as performance athletic wear use as rugged all-terrain footwear |
Level 2 - Moderate Risk*
These individuals demonstrate sensory loss (inability to perceive the Semmes-Weinstein 5.07 monofilament) and may have one of the following additional findings:
(1) Diminished circulation as evidenced by absent or weakly palpable pulses. (2) Foot deformity or minor foot infection and a diagnosis of diabetes. (3) These individuals require therapeutic footwear and orthoses to accommodate foot deformities, to compensate for soft tissue atrophy, and to evenly distribute plantar foot pressures. NOTE: May require Diabetic Socks and Depth Inlay Shoes based on clinical judgment. (a) Diabetic Socks are defined as hosiery specifically designed to reduce pressure or friction to the foot (see subpar. 3d(4)(b)1). (b) Depth Inlay Shoes which are prefabricated shoes with a higher toe box to accommodate for hammer toes and other foot deformities. This shoe may also accommodate the insertion of special inserts (see subpar. 3d(4)(b)2). |
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Type 3- Specialty service and extra duty custom molded footwear
Are intended
for use in the normal activities of daily living for integration in lower extremity brace devices for use as ankle stabilization devices for use in the management of venous and arterial insufficiency for use as oil/solvent resistant footwear for use as industrial/commercial skid resistant footwear Are not purpose intended
for use as rugged service work shoes for use as uniformed service boots for waterproof applications for use as under water mobility footwear for use as performance athletic wear for use as rugged all terrain footwear |
Level 3 - High Risk*
These individuals demonstrate peripheral neuropathy with sensory loss (i.e., inability to perceive the Semmes-Weinstein 5.07 monofilament) and diminished circulation and foot deformity, or minor foot infection and a diagnosis of diabetes, or any of the following by itself:
(1) Prior ulcer, osteomyelitis or history of prior amputation; (2) Severe Peripheral Vascular Disease (PVD) (intermittent claudication, dependent rubor with pallor on elevation, or critical limb ischemia manifested by rest pain, ulceration or gangrene); (3) Charcot’s joint disease with foot deformity; and (4) End Stage Renal Disease. These individuals are at highest risk of lower extremity events, because: (a) Individuals in this category require extra depth footwear with soft molded inserts. They may require custom molded shoes and braces (e.g., double upright brace, patella tendon bearing orthoses, etc.) (b) More frequent clinic visits are required with careful observation, regular preventive foot care, and footwear modifications to include, based on clinical judgment: Diabetic Socks, Depth Inlay Shoes, or Custom-Molded Orthopedic Shoes |
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Type 4- Prescription in-shoe orthotic products
Are intended for
increased mobility. increased comfort. pain management. wound management. use in the normal activities of daily living. integration with lower extremity bracing systems. integration with specialty footwear. use as joint stabilization devices. |