Instant Total Contact Cast to Heal Diabetic Foot Ulcers (ITCC)

• Wound Evaluation and Healing: The lower extremity evaluation will include length, width, depth, and area of the ulcer before and after debridement. [ Time Frame: every 10 days, then every 4 months ] [ Designated as safety issue: Yes ]
  We will evaluate wounds at each clinical visit to ensure the absence of infection. At each study visit a research CRC will take photographs of the wound which will be planimetrically measured and assessed by a clinician unaware of specific study allocation. An ulcer will be considered "healed" when it is fully epithelialized with no drainage.
  
  

• Evaluation of Complications: At each visit the study nurse will interview patients and determine if they have experienced any adverse events. [ Time Frame: every 10 days, then every 4 months ] [ Designated as safety issue: Yes ]
  This includes exacerbation of existing condition or event. Infection of soft tissue or bone, amputation, need for incision and drainage, iatrogenic ulcer formation, deterioration of the ulcer being treated, hospital admission, surgery of the foot or amputation of the foot or leg will be considered as an adverse event.
  
  

This is an investigator blinded randomized, controlled clinical trial with three parallel treatment groups of 75 adult outpatients with diabetes mellitus and a foot ulcer. The study will be conducted at five university affiliated medical centers in Arizona and Texas. The study participants and nurse coordinator will not be blinded to the treatment after randomization. Investigators will be blinded to treatment group assignment.