Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures (DFE)
2021年11月8日 更新者：Temple University
The purpose of this study is to examine the effectiveness of a novel patient education strategy, compared to a standard diabetic foot education.
The proposed diabetic foot care education uses personal computer-animated plantar pressure data to educate patients on why and how they should care for their feet.
研究概览
地位
完全的
详细说明
Using block randomization, subjects with diabetes were assigned to either the standard or the enhanced education group.
The effectiveness of enhanced education was evaluated as measured by foot care behavior score, patient's interpretation of neuropathy scores, and the incidence of diabetic foot complications over a course of 1-year.
研究类型
介入性
注册 (实际的)
99
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- Gait Study Center; Temple University School of Podiatric Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female between the ages of 21 and 75 years (inclusive)
- Documented type 1 or type 2 diabetes mellitus
- Demonstrates peripheral neuropathy (defined as vibration perception threshold (VPT) ≥ 25 volts at the hallux, as quantified by a BioThesiometer, or unable to perceive a 10 gram Semmes-Weinstein monofilament in one four sites on the feet)
- Able to walk independently without the use of walking aids (cane, crutches, or walker)
- Able to speak and understand English
- Able to understand the information in the informed consent form and willing and able to sign the consent form
Exclusion Criteria:
- Amputation of either foot proximal to midfoot
- Presence of cutaneous ulceration in the lower extremity
- History of or active Charcot neuroarthropathy of either foot
- Severe peripheral vascular disease (ie. ischemic rest pain, 2-block claudication or gangrene)
- End stage kidney disease requiring hemodialysis, stroke, or widespread malignant disease
- Pregnant or nursing
- Life expectancy < 12 months
- Not willing or able to make the required follow-up visits
- Insufficient (corrected) vision to complete the questionnaires
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：enhanced foot care education
In addition to the standard diabetic foot self-care instruction, the importance of daily foot self-care was reinforced at baseline by viewing personal barefoot plantar pressure in gait
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In addition to the standard foot care education, personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated once at baseline visit.
The demonstration includes diabetic foot education on the topic of diabetic neuropathy and how barefoot walking can lead to skin breakdown and ulcer formation, which can lead to infection and eventual amputation.
The education also highlights the high plantar pressures experienced by individuals while barefoot versus in-shoe and how proper footwear is necessary in conjunction with other standard self-foot care measures to prevent injury and complications.
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有源比较器：Standard Foot Care Education
Reviewed the standard diabetic foot self-care instructions, including daily foot inspection and proper footwear at all times.
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At baseline, a trained staff individually reviewed and dispensed the following brochures: "Prevent diabetes problems: Keep your diabetes under control" (NIH Publication No. 07-4349) and "Prevent diabetes problems: Keep your feet and skin healthy" (NIH Publication No. 07-4282) along with a 1-page summary of each brochure.
Also, a 1-page supplementary diabetic shoe wear educational material was reviewed and dispensed.
"Keep your diabetes under control" stresses "sugar, blood pressure, and medication control, and nutrition and physical activity, and checking feet daily for cuts, blisters, sores, swelling, redness, or sore toenails."
"Keep your skin and feet healthy" emphasizes the importance of checking feet daily, highlighting diabetic foot complications that can arise from neuropathy, poor circulation and dry skin, and the importance of supportive, protective, and accommodative shoewear and annual foot exams.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Foot Care Behavior Score
大体时间：baseline, 1, 3,6,9 and 12 months
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Daily foot inspection - number (& % of participants) of participants who inspect their feet at least daily
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baseline, 1, 3,6,9 and 12 months
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Patient Interpretation of Neuropathy (PIN) Questionnaire
大体时间：Baseline, months 1, 3, 6, and 12.
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Participants who demonstrated an accurate interpretation of diabetic peripheral neuropathy (id2).
The score range from 1 (correct interpretation) to 5 (misinterpretation)
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Baseline, months 1, 3, 6, and 12.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Foot Complications
大体时间：1 year
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Number of participants with foot complications
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1 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jinsup Song, DPM, PhD、Temple University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2008年5月2日
初级完成 (实际的)
2011年9月7日
研究完成 (实际的)
2012年3月14日
研究注册日期
首次提交
2013年4月4日
首先提交符合 QC 标准的
2013年9月9日
首次发布 (估计)
2013年9月13日
研究记录更新
最后更新发布 (实际的)
2021年12月7日
上次提交的符合 QC 标准的更新
2021年11月8日
最后验证
2021年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.