Instant Total Contact Cast to Heal Diabectic Foot Ulcers

描述(申请人提供)：本研究的主要目的是评估传统的全接触铸型(TCC)、可拆卸铸型助行器(RCW)和一种称为即时全接触铸型(ITCC)的改良RCW的有效性。TCC是治疗糖尿病足部溃疡的理想黄金标准。尽管RCWS在降低足底峰值压力方面已被证明与TCC一样有效，但在临床试验中，伤口愈合的比例较小，愈合速度也慢于TCC。我们已经证明，这是因为合规性差。我们的试验数据表明，通过使用RCW并用弹性绷带或铸型胶带覆盖它，可拆卸装置是不可拆卸的，愈合参数相当于TCC。我们计划将225名有足部溃疡的糖尿病患者随机分为三个治疗组：TCC、ITCC和RCW，以评估20周内痊愈的比例、愈合率、并发症和治疗成本。我们将使用计算机活动监视器来监控活动。为了监控合规性，我们将在卸载设备中嵌入活动监视器，并将总活动与卸载设备的活动进行比较。我们相信TCC组和ITCC组的愈合参数是相同的，而且两者都明显好于RCW组。此外，我们预计ITCC的成本将低于TCC。

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.