Therapeutic Stockings to Prevent Foot Ulcers

描述(申请人提供)：这项研究的目的是评估治疗长袜在降低高危糖尿病患者足部溃疡发生率方面的有效性，并评估治疗组中自我报告的功能状态。我们预计，接受治疗袜子治疗的受试者足部溃疡将较少，他们自我报告的功能状态将高于接受标准护理的患者。即使在有专门足部诊所的中心，有足部溃疡病史的糖尿病患者每年的复发率也超过30%。治疗长袜是一种廉价而实用的机制，可以减少脚部的压力和剪切力，从而减少溃疡的可能性。然而，几乎没有临床证据支持使用“治疗性长袜”。我们将随机选择400名有足部溃烂病史的糖尿病患者接受标准治疗(ST)，包括教育、定期足部护理以及保护性鞋子和鞋垫；或标准治疗加穿治疗性袜子。这项研究中使用的袜子旨在减少袜脚交界处的压力和摩擦。将使用NeuroQol仪器来评估自我报告的功能状态。我们将在德克萨斯州坦普尔、德克萨斯州乔治敦和英国曼彻斯特的两个中心为患者提供服务。在筛查和提供防护鞋和鞋垫后，患者将至少每三个月接受一次定期足部护理评估。患者将在日志中记录治疗用袜子、鞋垫和鞋子的日常使用情况。患者将使用步数计数器来记录日常活动。治疗长袜是一种廉价而实用的工具，可以保护高危患者的脚不受压力和剪切力的影响。这一简单的措施可能会显著降低高危患者的足部溃疡风险。

DESCRIPTION (provided by applicant): The objective of this study is to evaluate the effectiveness of therapeutic stockings to reduce the incidence of foot ulcers in high-risk diabetics, and to evaluate self-reported functional status among treatment groups. We expect that subjects treated with therapeutic stockings will have fewer foot ulcers and that their self-reported functional status will be higher than patients receiving standard care. Persons with diabetes with previous foot ulceration have a yearly recurrence rate of more than 30%, even at centers with specialized foot clinics. Therapeutic stockings are an inexpensive and practical mechanism to reduce pressure and shear forces on the foot and thereby reduce the likelihood of ulceration. However, there is very little clinical evidence to support the use of "therapeutic stockings". We will randomize 400 persons with diabetes and a history of foot ulceration to receive standard therapy (ST) consisting of education, regular foot care and protective shoes and insoles; or standard therapy with the addition of therapeutic stockings. The stockings used in this study are designed to reduce pressure and friction at the stocking-foot interface. The NeuroQol instruments will be administered to evaluate self-reported functional status. We will patients at centers in Temple, Texas, Georgetown, Texas, and two centers in Manchester, UK. Patients will be evaluated at least every three months for regular foot care after screening and provision of protective shoes and insoles. Patients will record daily use of therapeutic stockings, insoles and shoes in a log book. Patients will use a step counter to record daily activity. Therapeutic stockings are an inexpensive and practical tool to protect the feet of high risk patients from pressure and shear forces. This simple measure may significantly reduce the risk of foot ulcers in high risk patients.