DESIGN AND PILOT TESTING OF THE DVA SEATTLE FOOTWEAR SYSTEM FOR DIABETIC-PATIENTS WITH FOOT INSENSITIVITY/

Clinical epidemiology studies suggest the majority of lower limb amput ations were preceded by a minor traumatic event, often footwear-relate d, and lower Limb ulcers. To reduce foot trauma and ulcers, the diabet ic patient with foot insensitivity has unique footwear needs. To addre ss these needs for patients not requiring custom shoes, the DVA/Seattl e Footwear System was developed. The six components of this system inc lude: 1) a specially designed shoe last based on the geometry of the d iabetic foot and research findings on foot regions at highest risk of ulceration, 2) a depth-inlay shoe, ''Custom Stride(TM) by PRS,'' desig ned to be paired with either a custom-fabricated cork insole or a pref ormed polyurethane insole, 3) a laser digitizing system that captures 3-D plantar foot contours, 4) DVA/Seattle ShapeMaker(TM) software adap tation for modifying plantar surface contours and applying free-form a nd template modifications to increase or relieve loading, 5) software that translates files into code used by a milling machine to define th e cutting path and carve cork blockers into custom insoles, and 6) a p reformed polyurethane insole thicker than a typical insole to accommod ate the extra volume and the interior dimensions of the shoe. A 6-mont h pilot cross-over trial of 24 diabetic male veterans without prior fo ot ulcers was conducted to determine the feasibility of producing, and the safety of wearing, these depth-inlay shoes and both types of inso les. During the first 4 weeks, patients were assigned to the study sho es and one type of insole. During the next 4 weeks, they wore the othe r type of insole, and during the final 4 months, they chose which pair of insoles to wear with the study shoes. Over 150 person-months of fo otwear observation revealed no breaks in the cutaneous barrier with us e of either cork or polyurethane insoles and the study shoes. Patient compliance with the footwear was 88%. Patients were highly satisfied w ith the appearance, stability, and comfort of the shoes and the comfor t of both types of insole. However, 75% of the patients noted that the study shoes felt heavier than their customary shoes. Further research is needed to determine the long-term effectiveness of footwear in pre vention of foot ulcers in the population at highest risk for diabetic reulceration and amputation.