Therapeutic Stockings to Prevent Foot Ulcers

• The main clinical outcome is ulceration of the foot to evaluate the effectiveness of a stocking as a prevention tool [ Time Frame: every 12 weeks for 30 months ] [ Designated as safety issue: No ]
  An ulceration will be defined as full thickness loss of epidermis and dermis or involvement of deeper structures. Secondary clinical outcomes will include infection, Charcot Arthropathy, and amputation. An infection will be defined as a patient with three of six clinical signs of infection (erythema, heat, edema, pain, loss of function, purulence) or leukocytosis. Osteomyelitis will be diagnosed when radiographic and clinical signs are consistent with bone infection. This will be confirmed with bone biopsy, culture and histopathology when appropriate.
  
  

We will identify a cohort of high-risk diabetic patients and assign them to two treatment groups. We plan to enroll patients from three sites: Scott and White Hospital in Temple Texas, Manchester Royal Infirmary, UK , and Trinity College Dublin at St James Hospital.. The two treatment arms will involve a Standard Therapy Group, and a Stocking Therapy Group. The Stocking Therapy group will use the special padded and friction reducing stockings in their standard shoes during the course of the study. Patient enrollment will occur over a one-year period. All patients will be followed for 30 months. The Standard Therapy Group will receive therapeutic shoes, standard insoles, patient education and regular foot evaluations by a physician every 10-12 weeks. The Stocking Therapy Group will receive standard therapy as described above but use the special stockings instead of their usual hose. The investigator at each site will be blinded regarding the treatment.