Do CrocsRx Clogs Reduce Dynamic Plantar Pressure as Compared to Conventional House Shoes in Subjects With Diabetes?
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Comparison of peak pressure sub-metatarsal 2 and hallux in usual house shoes versus the CrocsRx clogs
研究概览
简要总结
Foot complications are a common and costly problem for subjects with diabetes. Although Medicare provides a pair of diabetic shoes yearly for subjects with diabetes, many do not wear their diabetic shoes in and around their house. Instead, subjects may wear shoes, such as flip flops or slippers, that provide little to no protection against injuries. While proper house shoe is important in the prevention of diabetic foot complications, this area has not received much attention. The purpose of this pilot study is to assess if CrocsRx Medical silver cloud clogs - a lightweight clog with protective toe box, cushioning soles, and easy to don and doff - offer reduced dynamic plantar pressure magnitude, as compared to conventional house shoes, for subjects with diabetes. A Repeated Measures ANOVA study design will be used to assess dynamic plantar pressure in 2 shod conditions for each subject with the order of shoes randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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 (inclusive)
- •Documented type 1 or type 2 diabetes mellitus
- •Demonstrated abnormal foot biomechanics by the presence of intractable plantar keratoma (IPK) beneath metatarsal heads or hallux
- •Participants with and without signs of peripheral neuropathy (unable to perceive a 10 gram monofilament or vibration perception threshold (VPT > 25 Volts)
- •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 consent form and willing and able to sign the consent form
排除标准
- •History of lower limb amputations (excluding toe amputations)
- •Presence of cutaneous ulceration in the lower extremity
- •History of or active Charcot neuroarthropathy of either foot
- •Severe peripheral vascular disease (i.e. ischemic rest pain, 2-block claudication, or gangrene)
- •End stage kidney disease requiring hemodialysis, stroke, or widespread malignant disease
- •Pregnant or nursing
- •Not willing or able to make the required follow-up visits
- •Insufficient (corrected) vision to complete the questionnaire
- •Unable to fit into available shoe sizes
结局指标
主要结局
Comparison of peak pressure sub-metatarsal 2 and hallux in usual house shoes versus the CrocsRx clogs
时间窗: At visit 1.
In-shoe plantar pressures will be measured using novel pedar-X system on subjects with diabetes while walking in 2 shod conditions: (1) their usual house shoe and (2) the CrocsRx clogs.
次要结局
未报告次要终点
研究者
Jinsup Song
Director, Gait Study Center
Temple University