Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic Gait Correction in Reducing Diabetic Foot Ulceration Or Subsequent Amputation in Patients With a History of a Diabetic Foot Ulceration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Number of re-ulceration occurrences
研究概览
简要总结
Determining whether the utilization of Noraxon myoRESEARCH Software gait analysis Evaluation and orthotic gait Correction can reduce diabetic foot ulceration Or subsequent amputation in patients with a history of a diabetic foot ulceration.
详细描述
The purpose of this study is to identify emerging abnormal structural pathology of the vulnerable re-ulcerative diabetic foot incorporating physical therapy evaluation as well as the Noraxon gait analysis to generate quantitative and qualitative gait data. Once peak foot pressures and gait pathology is identified, gait remedy is fabricated including either a foot orthotic and/or an ankle foot prosthesis. Evaluation of constructed remedy will then be evaluated focusing on gait analysis data to validate decreased plantar foot peak pressures and gait realignment towards the reduction of the diabetic foot re-ulceration and subsequent foot or limb loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of healed diabetic foot ulceration
- •Over 18 years of age
排除标准
- •Patients who are:
- •under 18 years of age
- •non-diabetic
- •non-ambulatory
- •non-healed wounds.
结局指标
主要结局
Number of re-ulceration occurrences
时间窗: One year
Number of re-ulceration occurrences will be assessed to determine the rate of re-ulceration in patients.
次要结局
- Change of length of gait (m)(Every 3 months, up to one year)
- Number of major proximal amputation occurrences(One year)
- Location of amputation(One year)
- Number of patients who remain in remission(One year)
- Percentage of patients who do not experience re-ulceration after custom orthosis(One year)
- Change of peak plantar pressure (n/cm^2)(Every 3 months, up to one year)