ISRCTN15526470已完成2 期
An investigation of a smart insole, for the purpose of improving sensory response in people with diabetic peripheral neuropathy - SMARTSOLE
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
研究概览
简要总结
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38536962/ (added 06/06/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Diagnosis of type 2 diabetes mellitus
- •2. Aged >18 years
- •3. Presence of at least one pedal pulse
- •4. Presence of moderate diabetic peripheral neuropathy defined by a vibration perception threshold > 15V
- •5. Ability to walk unaided for 30 steps
- •6. Able to understand all of the study requirements
- •7. Fit shoe size UK 8-12
排除标准
- •1. Active foot ulcer
- •2. NHS prescription footwear
- •3. Lower limb amputation (anything more than amputation of two lesser toes)
- •4. Severe deformity due to Charcot Neuroarthropathy
- •5. Major foot deformities, including diabetes and non-diabetes-related deformities
- •6. Dementia or other cognitive impairment
- •7. Significant cardiopulmonary or other systemic disease limiting the patient’s ability to walk 30 steps
- •8. Person with bodyweight greater than 100kg (due to insole device limitations)
- •9. Use of a pacemaker
- •10. Inability to understand verbal and written information in English
研究者
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