In-shoe pressure analysis in patients with a history of diabetes-related foot ulceration: a mixed methods study

Abstract Background Medical grade footwear (MGF) with demonstrated plantar-pressure reducing effect is recommended to reduce the risk of diabetes-related foot ulceration (DFU). Efficacy of MGF relies on high adherence (≥ 80%). In-shoe pressure analysis (IPA) is used to assess and modify MGF, however, there is limited evidence for the impact on patient adherence and understanding of MGF. The primary aim of this study was to determine if self-reported adherence to MGF usage in patients with previous DFU improved following IPA compared to adherence measured prior. The secondary aim was to determine if patient understanding of MGF improved following in-shoe pressure analysis. Methods Patients with previous DFU fitted with MGF in the last 12 months were recruited. The first three participants were included in a pilot study to test procedures and questionnaires. MGF was assessed and modified at Week 0 based on findings from IPA using the Pedar system (Novel). Patients completed two questionnaires, one assessing patient adherence to MGF at Week 0 and Week 4, the other assessing patient understanding of MGF before and after IPA at week 0. Patient understanding was measured using a 5-point Likert scale (strongly disagree 1 to strongly agree 5). Patient experience was assessed via a telephone questionnaire administered between Weeks 0–1. Results 15 participants were recruited, and all completed the study. Adherence of ≥ 80% to MGF usage inside the home was n = 2 (13.3%) pre-IPA and n = 3 (20.0%) at Week 4. Outside the home, ≥ 80% adherence to MGF was n = 8 (53.3%) pre-IPA, and n = 12 (80.0%) at Week 4. All participants reported that undergoing IPA improved their understanding of the value of MGF and that undergoing the intervention was worthwhile and beneficial. Conclusions Self-reported adherence inside the home demonstrated minimal improvement after 4 weeks, however, adherence of ≥ 80% outside the home increased by 27%, with 80% of all participants reporting high adherence at Week 4. Participants rated their learnings from the experience of IPA as beneficial.