Objectively assessed long‐term wearing patterns and predictors of wearing orthopaedic footwear in people with diabetes at moderate‐to‐high risk of foot ulceration: a 12 months observational study

Abstract

Background 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. Methods 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. Results 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 (R2 = 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. Conclusions 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. Trial registration Netherlands Trial Register NL7710. Registered: 6 May 2019.

Offloading and adherence through technological advancements: Modern approaches for better foot care in diabetes

“…Risk-factor studies have shown that factors like diabetes history, body mass index, footwear appearance, being indoors, patient expectations towards efficacy, and postural issues influence adherence rates, although the explained variance is still not very high and 25% at maximum. 11,[15][16][17][18][19][20][21][22] Nevertheless, these factors should be considered and where modifiable targeted in assessing treatment adherence and determining the treatment plan to improve adherence.…”

“…The fact that many patients do not wear their offloading device or prescribed footwear as recommended may be related to demographic, psycho‐social, environmental, contextual and device or shoe‐related factors. Risk‐factor studies have shown that factors like diabetes history, body mass index, footwear appearance, being indoors, patient expectations towards efficacy, and postural issues influence adherence rates, although the explained variance is still not very high and 25% at maximum 11,15–22 . Nevertheless, these factors should be considered and where modifiable targeted in assessing treatment adherence and determining the treatment plan to improve adherence.…”