Research & Development, Voetencentrum Wender, Hengelo, 7555 SK, The Netherlands.
Department of Psychology, Health and Technology, Centre for eHealth Research and Wellbeing, University of Twente, Enschede, 7500 AE, The Netherlands.
J Foot Ankle Res. 2023 Sep 14;16(1):60. doi: 10.1186/s13047-023-00656-6.
Orthopaedic footwear can only be effective in preventing diabetic foot ulcers if worn by the patient. Robust data on long-term wearing time of orthopaedic footwear are not available, and needed to gain more insights into wearing patterns and associated factors (i.e. participants' demographic, disease-related characteristics, and footwear usability). We aimed to objectively assess long-term wearing patterns and identify factors associated with wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of ulceration.
People diagnosed with diabetes mellitus type 1 and 2 with loss of protective sensation and/or peripheral artery disease and prescribed with orthopaedic footwear were included and followed for 12 months. The primary outcome was mean daily wearing time, continuously measured using a temperature sensor inside the footwear (Orthotimer®). Adherence to wearing orthopaedic footwear was calculated as percentage of wearing time of a total assumed 16 h out-of-bed daytime, where adherence < 60% was a pre-determined non-adherent threshold. Wearing time patterns were assessed by calculating participants' wearing (in)consistency. One-way analyses of variance tested for wearing time differences between subgroups, weekdays, and weekend days. Factors potentially associated with wearing time were collected by questionnaires and medical files. Univariately associated factors were included in multivariate linear regression analysis.
Sixty one participants were included (mean (SD) age: 68.0 (7.4) years; females: n = 17; type 2 diabetes mellitus: n = 54). Mean (SD) overall daily wearing time was 8.3 (6.1) hours/day. A total of 40 (66%) participants were non-adherent. Participants with a consistent wearing pattern showed higher daily wearing times than participants with an inconsistent pattern. Mean (SD) wearing times were 12.7 (4.3) vs 3.6 (4.8) hours/day, respectively (P < 0.001). Mean (SD) wearing time was significantly higher (P < 0.010) during weekdays (8.7 (6.0) hours/day) compared to Saturday (8.0 (6.1) hours/day) and Sunday (6.9 (6.2) hours/day). In the multivariate model (R = 0.28), "satisfaction with my wear of orthopaedic footwear" was positively associated (P < 0.001) with wearing time. The other seven multivariate model factors (four demographic variables and three footwear usability variables) were not associated with wearing time.
Only one out of three people at moderate to high risk of foot ulceration were sufficiently adherent to wearing their orthopaedic footwear. Changing people's wearing behaviour to a more stable pattern seems a potential avenue to improve long-term adherence to wearing orthopaedic footwear. Investigated factors are not associated with daily wearing time. Based on these factors the daily wearing time cannot be estimated in daily practice.
Netherlands Trial Register NL7710. Registered: 6 May 2019.
矫形鞋只有在患者穿着的情况下才能有效预防糖尿病足溃疡。目前还没有关于矫形鞋长期穿着时间的可靠数据，需要更多地了解穿着模式和相关因素（即参与者的人口统计学、疾病相关特征和鞋类可用性）。我们旨在客观评估长期穿着模式，并确定与糖尿病患者穿着矫形鞋相关的因素，这些患者有中度至高度溃疡风险。
纳入诊断为 1 型和 2 型糖尿病且有保护性感觉丧失和/或外周动脉疾病并开具矫形鞋处方的患者，并随访 12 个月。主要结局是使用鞋内的温度传感器（Orthotimer®）连续测量的平均每日穿着时间。将矫形鞋的依从性计算为假设 16 小时非卧床白天总穿着时间的百分比，其中依从性<60%为预先确定的非依从性阈值。通过计算参与者的穿着（不）一致性来评估穿着时间模式。单因素方差分析用于测试亚组、工作日和周末日之间的穿着时间差异。通过问卷和病历收集可能与穿着时间相关的因素。单变量相关因素被纳入多元线性回归分析。
共纳入 61 名参与者（平均（SD）年龄：68.0（7.4）岁；女性：n=17；2 型糖尿病：n=54）。总体平均（SD）每日穿着时间为 8.3（6.1）小时/天。共有 40 名（66%）参与者不依从。具有一致穿着模式的参与者的每日穿着时间高于具有不一致模式的参与者。平均（SD）穿着时间分别为 12.7（4.3）和 3.6（4.8）小时/天（P<0.001）。工作日（8.7（6.0）小时/天）的平均（SD）穿着时间明显高于星期六（8.0（6.1）小时/天）和星期日（6.9（6.2）小时/天）（P<0.010）。在多元模型（R=0.28）中，“对我穿着矫形鞋的满意度”与穿着时间呈正相关（P<0.001）。多元模型的其他七个因素（四个人口统计学变量和三个鞋类可用性变量）与穿着时间无关。
在中度至高度足部溃疡风险的人群中，只有三分之一的人足够依从地穿着矫形鞋。将人们的穿着行为改变为更稳定的模式，似乎是提高长期依从性的潜在途径。研究因素与每日穿着时间无关。根据这些因素，无法在日常实践中估计每日穿着时间。
荷兰试验注册 NL7710。注册时间：2019 年 5 月 6 日。
