Therapeutic Stockings to Prevent Foot Ulcers

描述（由申请人提供）：本研究的目的是评估治疗性丝袜在减少高风险糖尿病患者足部溃疡发生率方面的有效性，并评估治疗组患者自我报告的功能状态。我们期望用治疗性丝袜治疗的受试者会有更少的足溃疡，并且他们自我报告的功能状态会比接受标准治疗的患者高。糖尿病患者既往足部溃疡每年复发率超过30%，即使在有专门足部诊所的中心也是如此。治疗性长袜是一种廉价和实用的机制，可以减少脚上的压力和剪切力，从而减少溃疡的可能性。然而，很少有临床证据支持使用“治疗袜”。我们将随机选择400名有足部溃疡史的糖尿病患者接受标准治疗（ST），包括教育、定期足部护理和防护鞋和鞋垫；或者标准疗法加上治疗袜。在这项研究中使用的长袜是为了减少袜脚界面的压力和摩擦。NeuroQol仪器将用于评估自我报告的功能状态。我们将在德克萨斯州坦普尔、乔治城和英国曼彻斯特的两个中心对患者进行研究。在筛查和提供防护鞋和鞋垫后，患者将至少每三个月进行一次定期足部护理评估。患者将在日志簿中记录每天使用治疗袜、鞋垫和鞋子的情况。患者将使用计步器记录日常活动。治疗袜是一种廉价和实用的工具，可以保护高风险患者的脚免受压力和剪切力的影响。这一简单的措施可以显著降低高风险患者足部溃疡的风险。

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.