Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Foot Care Behavior Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Foot Care Behavior Score
时间窗: baseline, 1, 3,6,9 and 12 months
Daily foot inspection - number (\& % of participants) of participants who inspect their feet at least daily
Patient Interpretation of Neuropathy (PIN) Questionnaire
时间窗: Baseline, months 1, 3, 6, and 12.
Participants who demonstrated an accurate interpretation of diabetic peripheral neuropathy (id2). The score range from 1 (correct interpretation) to 5 (misinterpretation)
次要结局
- Foot Complications(1 year)