OBJECTIVE To evaluate prospectively a risk categorization scheme for lower-extremity problems that incorporates the Semmes-Weinstein 5.07 monofilament and a simple exam to stratify patients who were followed in a primary-care setting into risk groups for plantar ulceration and lower-extremity amputation.

RESEARCH DESIGN AND METHODS Patients with diabetes in a well-defined American-Indian population were stratified into four risk categories based on sensation status to the 5.07 monofilament, the presence of foot deformity, and a history of lower-extremity events (amputation or ulceration): category 0, sensate; category 1, insensate; category 2, insensate with deformity; and category 3, history of lower extremity events. Patients were followed prospectively for lower extremity events and changes in sensation status.

RESULTS We gave screening exams to 358 (88%) of 406 individuals with diabetes in the community. The distribution of patients for risk categories 0, 1, 2, and 3 was 74.3, 8.4, 4.5, and 13%, respectively. Over a 32-mo follow-up period, 41 patients developed ulcerations, and incidence rates correlated positively with increasing risk category (P < 0.00001). All 14 amputations occurred in risk groups 2 and 3.

CONCLUSIONS These data suggest that the risk categorization described here may have a role in identifying patients at risk for lower extremity events who are followed in a primary-care setting.