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 人开始时间: 2013年10月4日最近更新: 2021年5月3日

适应症

试验速览

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)

•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

•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

发起方

Manchester Metropolitan University (UK)