We aimed to investigate adherence to at-home monitoring of foot temperature and its association with patient-, disease- and behavior-related factors, in people with diabetes at high risk of ulceration. We analyzed 151 participants in the enhanced therapy arm of the DIATEMP trial (all at high diabetes-related foot ulcer risk) who aimed to perform and log foot temperatures daily for 18 months or until ulceration. Adherence was the proportion of measurement days covered (PDC), with being adherent defined as PDC≥70%. If a hotspot was recorded, adherence to subsequently reducing ambulatory activity was assessed. Multivariate logistic regression analysis was performed to investigate associations with adherence. We found ninety-four participants (62.3%) adherent to measuring foot temperatures. This was higher in months 1-3 versus months 4-18: 118 (78.1%) versus 78 (57.4%; P < .001). Of 83 participants with a hotspot, 24 (28.9%) reduced ambulatory activity. Increasing age ( P = .021, OR = 1.045) and better self-care ( P = .007, OR = 1.513) were positively associated with adherence to measuring foot temperature. In conclusion, in people at high diabetes-related foot ulcer risk, adherence to measuring foot temperature was high in the first months after study commencing, but dropped over time. Adherence to reducing ambulatory activity when a hotspot was found was low over the entire study period.

Adherence to prescribed footwear is essential to prevent diabetes-related foot ulcers. The aim was to compare different measures of adherence and wearing time of prescribed footwear with a reference adherence measure, among people with diabetes at high risk of foot ulceration. We followed 53 participants for 7 consecutive days. A temperature sensor measured wearing time of prescribed footwear and a triaxial accelerometer assessed weight-bearing activities. Subjective wearing time was self-reported. Reference adherence measure was proportion of weight-bearing time prescribed footwear was worn. We calculated Spearman’s correlation coefficients, kappa coefficients, and areas under the curve (AUC) for the association between the reference measure and other measures of adherence and wearing time. Proportion of daily steps with prescribed footwear worn had a very strong association (r = 0.96, Κ = 0.93; AUC: 0.96–1.00), objective wearing time had a strong association (r = 0.91, Κ = 0.85, AUC: 0.89–0.99), and subjective wearing time had a weak association (r = 0.42, Κ = 0.38, AUC: 0.67–0.81) with the reference measure. Objectively measured proportion of daily steps with prescribed footwear is a valid measure of footwear adherence. Objective wearing time is reasonably valid, and may be used in clinical practice and for long-term measurements. Subjective wearing time is not recommended to be used.

Foot ulcers are a frequent and costly problem in people with diabetes mellitus and can lead to amputations. Prevention of these ulcers is therefore of paramount importance. Claw/hammer toe deformities are commonly seen in people with diabetes. These deformities increase the risk of ulcer development specifically at the (tip of) the toe. Percutaneous needle tenotomy of the tendon of the m. flexor digitorum longus (tendon tenotomy) can be used to reduce the severity of claw/hammer toe deformity with the goal to prevent ulcer recurrence. The main objective of this randomized controlled trial is to assess the efficacy of flexor tenotomy to prevent recurrence of toe ulcers in people with diabetes and a history of toe (pre-)ulcers. Additionally, we aim to assess interphalangeal joints (IPJ) and metatarsophalangeal joint (MTPJ) angles in a weight-bearing and non-weight-bearing position, barefoot plantar pressure during walking, cost-effectiveness and quality of life before and after the intervention and compare intervention and control study groups. Sixty-six subjects with diabetes and claw/hammer toe deformity and a recent history of (pre-)ulceration on the tip of the toe will be included and randomized between flexor tenotomy of claw/hammer toes (intervention) versus standard of care including orthosis and shoe offloading (controls) in a mono-center randomized controlled trial. NCT05228340.

Introduction: Adherence to wearing prescribed footwear is paramount in reducing the risk of developing diabetes‐related foot ulcers, but adherence is often lower than optimal. This study aimed to investigate predictors of footwear adherence and variations in adherence and activity in people at risk of diabetes‐related foot ulceration.Methods: Sixty people at high foot ulcer risk were included. We measured the proportion of weight‐bearing acitivity time the prescribed footwear was worn for seven days. Multiple linear regression and analysis of variance were used.Results: Mean overall adherence was 63%. Adherence was lower at home than away from home (59% vs. 74%), while activity was higher at home (2.2 vs. 1.2 h/day). Adherence was similar across activities (61%–63%). No variable predicted the overall adherence. Higher Hba1c predicted lower adherence at home (β = −0.34, p = 0.045, R² = 11.6%). More daily steps predicted lower adherence away from home (β = −0.30, p = 0.033, R² = 9.3%). Adherence and activity were highest in mornings (71%, 1.1 h) and afternoons (71%, 1.5 h), and lower in evenings (40%, 0.8 h) and at nights (9%, 0.1 h). Adherence was similar on weekdays and weekend days (63% vs. 60%), but activity was higher on weekdays (3.4 vs. 3.0 h).Conclusion: Adherence levels and predictors thereof differed between adherence at home and away from home, so we suggest to treat them as different concepts. Due to the low explained variance, future studies should focus on other predictors such as psychological variables.

Pressure-relieving footwear helps prevent foot ulcers in people with diabetes. The footwear design contributes to this effect and includes the insole top cover. We aimed to assess the offloading effect of materials commonly used as insole top cover. We measured 20 participants with diabetes and peripheral neuropathy for in-shoe peak pressures while walking in their prescribed footwear with the insole covered with eight different materials, tested in randomized order. Top covers were a 3 mm or 6 mm thick open or closed-cell foam or a 6 mm thick combination of open- and closed-cell foams. We re-assessed pressures after one month of using the top cover. Peak pressures were assessed per anatomical foot region and a region of interest (i.e., previous ulceration or high barefoot pressure). Walking comfort was assessed using a 10-point Likert scale. Mean peak pressure at the region of interest varied between 167 (SD:56) and 186 (SD:65) kPa across top covers (p < 0.001) and was significantly higher for the 3 mm thick PPT than for four of the seven 6 mm thick top covers. Across 6 mm thick top covers, only two showed a significant peak pressure difference between them. Over time, peak pressures changed non-significantly from −2.7 to +47.8 kPa across top cover conditions. Comfort ratings were 8.0 to 8.4 across top covers (p = 0.863). The 6 mm thick foams provided more pressure relief than the 3 mm thick foam during walking in high-risk people with diabetes. Between the 6 mm thick foams and over time, only small differences exist. The choice of which 6 mm thick insole top cover to use may be determined more by availability, durability, ease of use, costs, or hygienic properties than by superiority in pressure-relief capacity.

Aims: Plantar foot ulcers are a burdensome complication of diabetes caused by abnormal foot biomechanics. Predicting foot ulcers aids in their prevention, but the value of peak pressure—the most used biomechanical parameter—is only moderate. We aimed to improve prediction based on the more comprehensive load measure cumulative plantar tissue stress (CPTS).Methods: We prospectively observed 60 participants with diabetes at high foot ulcer risk for 12 months. At baseline, we assessed demographic and clinical characteristics—including plantar pre‐ulcers (i.e., abundant callus, haemorrhage, blister, fissure)—and measured barefoot and in‐shoe plantar pressures during walking and standing. Daily‐life weight‐bearing activity and adherence to prescribed footwear were assessed over 7 days after baseline. The primary outcome was plantar foot ulceration during the 12‐month follow‐up. CPTS was calculated (in GPa^.s/day) from the above foot‐loading factors and analysed for predicting foot ulcers and its association with pre‐ulcers, using multivariate regression analyses.Results: Twenty‐two participants (37%) developed a plantar forefoot ulcer. CPTS was not a significant predictor (odds ratio (OR) = 0.90 (95% confidence interval (CI): 0.50–1.59)) but pre‐ulcers at baseline (OR = 9.97, 95%CI: 1.41–70.65) and walking speed (in m/s) (OR = 0.01, 95%CI: 0.00–0.32) were. CPTS was significantly associated with pre‐ulcers (OR = 2.38, 95%CI: 1.02–5.54).Conclusions: CPTS did not predict plantar foot ulceration in our high‐risk participants, but our findings support the mechanical pathway of plantar foot ulceration through pre‐ulcer development and indicate lower walking speed as an important predictor. Assessing walking speed and early identifying and treating pre‐ulcers will help predict and prevent plantar foot ulcers in high‐risk people with diabetes.