Instant Total Contact Cast to Heal Diabectic Foot Ulcers

描述（由申请人提供）：本研究的主要目的是评估传统的全接触铸造（TCC），可移动铸造助行器（RCW）和RCW的改进，称为即时全接触铸造（ITCC）的有效性。tcc是治疗糖尿病足溃疡的理想金标准。尽管rcw已被证明与tcc一样有效地降低足底的峰值压力，但在临床试验中，伤口愈合的比例更小，愈合速度也比tcc慢。我们已经证明，这是由于依从性差。我们的试验数据表明，采用RCW并用弹性绷带或铸带覆盖，可移动装置是不可移动的，愈合参数相当于tcc。我们计划将225例糖尿病足部溃疡患者随机分为TCC、ITCC和RCW三个治疗组，评估20周内的愈合比例、愈合率、并发症和治疗费用。我们将用电脑活动监视器监视活动。为了监控合规性，我们将在卸载设备中嵌入一个活动监视器，并将总活动与使用卸载设备的活动进行比较。我们认为TCC组和ITCC组的愈合参数相同，且均明显优于RCW组。此外，我们预计ITCC将比TCC更便宜。

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.