ISRCTN05585501
已完成
未知
Prevention of foot ulcer recurrence in diabetes patients using plantar pressure biofeedback: a randomised controlled trial
Manchester Metropolitan University (UK)0 个研究点目标入组 58 人2013年10月4日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Topic: Diabetes Research Network
- 发起方
- Manchester Metropolitan University (UK)
- 入组人数
- 58
- 状态
- 已完成
- 最后更新
- 5年前
概览
简要总结
2018 results presented at the 54th EASD Annual Meeting of the European Association for the Study of Diabetes in https://link.springer.com/content/pdf/10.1007%2Fs00125-018-4693-0.pdf [abstract 7] (added 24/06/2019) 2019 results in https://pubmed.ncbi.nlm.nih.gov/33323253/ (added 20/04/2021)
研究者
入排标准
入选标准
- •1\. Diagnosed with Type 1 or 2 diabetes
- •2\. A history of previous ulceration on the weight\-bearing surface of the foot
- •3\. Presence of neuropathy (defined by any loss of sensation)
- •4\. Ability to walk independently for approx. 100 metres (i.e., without use of wheelchair, walking stick or personal assistance)
- •5\. Aged \>18 years
- •6\. Able to understand all of the study requirements and have a life expectancy greater than the study duration
- •Target Gender: Male \& Female
排除标准
- •1\. Active foot ulcer
- •2\. In\-shoe orthotics consisting of non\-compressible materials
- •3\. Presence of severe ischaemia for either foot defined by complete absence of foot pulses and ankle\-brachial pressure index \<0\.6
- •4\. Lower limb amputation affecting the ability to walk approx. 100 metres
- •5\. Dementia, uncorrected visual or psychological impairment
- •6\. Psychiatric illnesses or social situations that would limit compliance with the study
- •7\. Inner ear pathology, or other serious underlying balance dysfunction
- •8\. Significant cardiopulmonary or other systemic disease limiting the patient's ability to walk approx. 100 metres unaided
- •9\. Current participation in another clinical investigation of a medical device or a drug, or participation in such a study within 30 days prior to study enrolment
- •10\. Body Mass Index (BMI) \>40
结局指标
主要结局
未指定
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