Therapeutic Stockings to Prevent Foot Ulcers

描述（由申请人提供）：本研究的目的是评价治疗性长袜降低高危糖尿病患者足部溃疡发生率的有效性，并评价治疗组中自我报告的功能状态。我们预计，与接受标准治疗的患者相比，接受治疗性长袜治疗的患者的足部溃疡较少，并且他们自我报告的功能状态将更高。患有糖尿病的人与以前的足部溃疡有超过30%的年复发率，即使在中心与专门的足部诊所。治疗袜是一种廉价和实用的机制，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名有糖尿病和足部溃疡病史的患者，接受标准治疗（ST），包括教育、定期足部护理和保护鞋和鞋垫;或标准治疗加治疗袜。本研究中使用的长统袜旨在减少长统袜-足部界面处的压力和摩擦。将使用NeuroQol工具评价自我报告的功能状态。我们将在得克萨斯州坦普尔、得克萨斯州乔治敦和英国曼彻斯特的两个中心接受患者治疗。在筛选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袜、鞋垫和鞋的每日使用情况。患者将使用步数计记录每日活动。治疗袜是一种廉价而实用的工具，以保护高风险患者的脚免受压力和剪切力。这种简单的措施可以显著降低高风险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.