ISRCTN16011830已完成未知
INSTEP: Insoles to Ease Pressure. A participant and assessor blinded, randomised multi-centre parallel group feasibility trial with embedded qualitative study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy
Plymouth University0 个研究点目标入组 61 人开始时间: 2017年10月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 61
研究概览
简要总结
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30904880 protocol (added 09/04/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36737812/ (added 06/02/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Confirmed diagnosis of type 1 or 2 diabetes as confirmed by medical records
- •2. Aged over 18 years
- •3. Identified clinical need for offloading insoles by podiatrist
- •4. Neuropathic (sensory peripheral diabetic neuropathy)
- •5. Palpable pedal foot pulses
- •6. Able and willing to comply with all trial requirement
排除标准
- •1. Any other significant disease or disorder which, in the opinion of the PI, may put the participant at risk of health deterioration, such as falls, because of their involvement in the trial
- •2. Non healing foot ulcer at another site that requires targeted off-loading
- •3. Unable to walk five metres with/without walking aid
- •4. Unable to stand on either leg independently for 10 seconds (+/- chair aid to assist in balance)
- •5. Lacking capacity or unwilling to give consent
- •6. Already wearing existing insoles that are clinically appropriate
- •7. Peripheral vascular disease (non-re-constructible vascular disease as determined by arterial duplex)
- •8. Unwilling to wear therapeutic footwear
- •9. Gross foot deformity e.g. charcot foot or fixed rear foot deformity
- •10. Unable to provide adequate consent to undertake the trial procedures
- •11. Major amputation of part of the foot
研究者
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