Design and biomechanical function of indoor-specific versus regular custom-made footwear for people with diabetes at high risk of foot ulceration

IF 1.4 3区医学 Q4 ENGINEERING, BIOMEDICAL

Clinical Biomechanics Pub Date : 2025-07-01 DOI:10.1016/j.clinbiomech.2025.106605

L.E. Vossen , J.J. van Netten , T.E. Busch-Westbroek , S.A. Bus

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引用次数: 0

Abstract

Background

Custom-made footwear designed specifically for indoor use increases footwear adherence in people with diabetes at high ulcer risk. The design and biomechanical requirements of such footwear are important if they are to safely replace regular custom-made footwear for indoor use. We aimed to compare indoor-specific versus regular custom-made footwear for design characteristics and biomechanical function.

Methods

Indoor-specific pressure-optimized custom-made footwear (i.e. lower weight, easier to don and doff, more comfortable and breathable materials) was provided to 36 participants with diabetes, neuropathy, and a recently healed plantar foot ulcer or amputation, who already had regular pressure-optimized custom-made footwear. Both footwear types were assessed for their shoe design features and compared using Cohen's Kappa and percentage agreement. In-shoe plantar pressures were measured during walking in both footwear types, from which multiple (center-of-)pressure parameters were calculated and compared using paired t-tests and statistical parametric mapping.

Findings

Of the 36 participants, a total 132 shoes, 66 per footwear type, were analyzed. Cohen's Kappa ranged from −0.17 to 0.72 for different design features and percentage agreement from 45 % to 97 %. Outcomes for all peak pressure parameters were statistically non-significantly higher (0–3 %, P > 0.05) in the indoor-specific compared to regular footwear. Center-of-pressure parameters were also not significantly different.

Interpretation

No statistically significant or clinically relevant differences were found in biomechanical functions between indoor-specific and regular custom-made footwear, despite differences found in footwear design. Indoor-specific footwear is thus a biomechanically safe alternative to regular custom-made footwear for use indoors in people with diabetes at high ulcer risk.

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足部溃疡高风险糖尿病患者室内专用鞋与常规定制鞋的设计和生物力学功能

背景：专为室内使用而设计的定制鞋增加了高溃疡风险糖尿病患者的鞋依从性。这种鞋子的设计和生物力学要求是很重要的，如果他们要安全地取代常规的定制的鞋子在室内使用。我们的目的是比较室内专用鞋与常规定制鞋的设计特征和生物力学功能。方法为36例患有糖尿病、神经病变、近期足底溃疡或截肢且已定期穿压力优化定制鞋的患者提供室内压力优化定制鞋（即重量更轻、穿脱更方便、材料更舒适透气）。两种鞋的设计特点都被评估，并使用科恩的Kappa和百分比协议进行比较。在两种鞋的行走过程中测量鞋内足底压力，从中计算多个（中心）压力参数，并使用配对t检验和统计参数映射进行比较。研究人员分析了36名参与者共132双鞋，每种鞋66双。不同设计特征的Cohen’s Kappa范围为- 0.17至0.72，一致性百分比为45%至97%。所有峰值压力参数的结果均无统计学意义(0 - 3%,P >；0.05)，与普通鞋相比。压力中心参数也无显著差异。解释：尽管在鞋类设计上存在差异，但在室内专用鞋类和常规定制鞋类的生物力学功能方面没有发现统计学上显著或临床相关的差异。因此，对于患有高溃疡风险的糖尿病患者来说，室内专用鞋是一种生物力学上安全的替代常规定制鞋。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Biomechanics 医学-工程：生物医学

CiteScore

3.30

自引率

5.60%

发文量

189

审稿时长

12.3 weeks

期刊介绍： Clinical Biomechanics is an international multidisciplinary journal of biomechanics with a focus on medical and clinical applications of new knowledge in the field. The science of biomechanics helps explain the causes of cell, tissue, organ and body system disorders, and supports clinicians in the diagnosis, prognosis and evaluation of treatment methods and technologies. Clinical Biomechanics aims to strengthen the links between laboratory and clinic by publishing cutting-edge biomechanics research which helps to explain the causes of injury and disease, and which provides evidence contributing to improved clinical management. A rigorous peer review system is employed and every attempt is made to process and publish top-quality papers promptly. Clinical Biomechanics explores all facets of body system, organ, tissue and cell biomechanics, with an emphasis on medical and clinical applications of the basic science aspects. The role of basic science is therefore recognized in a medical or clinical context. The readership of the journal closely reflects its multi-disciplinary contents, being a balance of scientists, engineers and clinicians. The contents are in the form of research papers, brief reports, review papers and correspondence, whilst special interest issues and supplements are published from time to time. Disciplines covered include biomechanics and mechanobiology at all scales, bioengineering and use of tissue engineering and biomaterials for clinical applications, biophysics, as well as biomechanical aspects of medical robotics, ergonomics, physical and occupational therapeutics and rehabilitation.