Instant Total Contact Cast to Heal Diabectic Foot Ulcers

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DESCRIPTION (provided by applicant): The primary objective of this study is to evaluate the effectiveness of traditional total contact casts (TCC), removable cast walkers (RCW) and a modification of a RCW, termed the instant total contact cast (ITCC). TCCs are the ideal gold standard to heal diabetic foot ulcers. Even though RCWs have been shown to be as effective as TCCs to reduce peak pressure on the sole of the foot, in clinical trials a smaller proportion of wounds heal, and the rate of healing is also slower than TCCs. We have demonstrated that this is because of poor compliance. Our pilot data indicates that by taking a RCW and covering it with an elastic bandage or cast tape, the removable device is irremovable and healing parameters are equivalent to TCCs. We plan to randomize 225 diabetics with foot ulcers into three treatment groups: TCC, ITCC and RCW to evaluate the proportion of healing in 20 weeks, the rate of healing, complications and cost of therapy. We will monitor activity with a computer activity monitor. To monitor compliance we will embed an activity monitor in the off-loading device and compare total activity to activity with the off-loading device. We believe that healing parameters will be the same in TCC and ITCC groups and both will be significantly better than the RCW group. In addition, we expect the ITCC to be less expensive than TCC.