Half of the 7,646 amputations performed in VA in 1996 were in veterans with diabetes. Lower extremity ulcers preceded about 85% of diabetic amputations. Minor trauma, often footwear or repetitive pressure related, initiated the majority of the ulcers. Persons with diabetes have unique footwear needs. In 1997, Gayle E. Reiber MPH, PhD, and Douglas G. Smith, MD of the VA Puget Sound Health Care System initiated a randomized clinical trial (1) to determine the extent to which study shoes and study inserts would reduce the incidence of re-ulceration in diabetic individuals with a prior foot ulcer history, and (2) to estimate costs of ulcer prevention using these strategies. A total of 400 patients from the VA Puget Sound Health Care System (n=189) and a Seattle-area Health Maintenance Organization, Group Health Cooperative (n=211), have now been randomized to one of three study arms: Arm 1 (n=120) study shoes and customized cork inserts; Arm 2 (n=119) study shoes and generic polyurethane inserts; and Arm 3 (n=161) controls who are wearing their own footwear. Patients in Arms 1 and 2 received formal, leisure and athletic shoes built to study specifications by Cole-Haan for men and by Lowell Shoe for women. Patients will be followed for two years to determine the incidence and cost of foot re-ulceration.