Use and usability of custom-made orthopedic shoes

The goal of this study was to investigate the use of custom-made orthopedic shoes (OS) and the association between the use of OS and the most relevant aspects of their usability. Over a 6-month period, patients meeting the inclusion criteria were recruited by 12 orthopedic shoe companies scattered throughout the Netherlands and asked to complete a questionnaire composed of a pre- and post-OS section. Patients with different pathologies were included in the study (n = 339; response 67%). Mean age of the patients was 63 +/- 15 years, and 38% were male. Three months after delivery, 81% of the patients used their OS frequently (4-7 days/week), 13% occasionally (1-3 days/week), and 6% did not use their OS. Associations were found between use and all measured aspects of usability (p-values varied from <0.001 to 0.028). Patients who used their OS more often had a more positive opinion regarding all the aspects of usability. We conclude that all aspects of the usability of OS are relevant in relation to their use and should be taken into account when prescribing and evaluating OS

Effect of awareness of being monitored on wearing of orthopaedic footwear

OBJECTIVE: To investigate the effect of awareness of being monitored on wearing time and adherence to wearing orthopaedic footwear. Quantitative assessment of wearing time was made using direct measurement with temperature sensors during the first 3 months after provision of footwear. DESIGN: Randomized controlled trial. INTERVENTION: Awareness that the temperature sensor is used for measuring wearing time. METHODS: All 55 participants had a temperature sensor built into the medial arch of the left insole of their orthopaedic footwear. Participants were assigned randomly to either an "awareness group" (n = 25, mean age 67 years) and knew they were being monitored for wearing time, or a "no awareness group" (n = 30, mean age 65 years) and only knew their shoe temperature was being measured. Differences were assessed with a linear mixed model. RESULTS: Mean (standard deviation; SD) wearing time in the intervention group was 7.32 h/day (SD 4.2), and 6.11 h/day (SD 4.1) in the control group (p = 0.017). A significant interaction effect was found between awareness and pathology group on wearing time (p = 0.036). The difference was especially large (7.0 (SD 4.7) vs 2.4 (SD 2.2) h/day) in the subgroup of people with diabetes. CONCLUSION: Awareness of being monitored increases wearing time and wearing of orthopaedic footwear

An explorative study on the validity of various definitions of a 2·2°C temperature threshold as warning signal for impending diabetic foot ulceration

Home monitoring of skin temperature is effective to prevent diabetic foot ulceration. We explored the validity of various definitions for the >2·2°C left-to-right threshold used as a warning signal for impending ulceration. Twenty patients with diabetes and peripheral neuropathy monitored their skin temperature with an infrared thermometer at the plantar hallux, metatarsal heads, midfoot and heel four times a day for 6 consecutive days. Environmental temperature and walking activity were monitored and associated with foot temperature. The average temperature difference between feet was 0·65°C. At single locations, a left-to-right temperature difference of >2·2°C was found 245 times (8·5% of measurements). Confirmation of these above-threshold readings on the following day was found seven times (0·3%). Corrected for individual left-to-right mean foot temperature differences, this reduced to four (0·2%). No ulcers developed in the week after monitoring. Left-to-right foot temperature differences were not significantly correlated with walking activity, environmental temperature or time of day. The >2·2°C left-to-right foot temperature threshold for impending ulceration is not valid as single measurement, but validity improves to acceptable levels when an above-threshold temperature difference is confirmed the following day and further improves with individual correction. The threshold is independent of time of day, environmental temperature and walking activity

The Association between Foot and Ulcer Microcirculation Measured with Laser Speckle Contrast Imaging and Healing of Diabetic Foot Ulcers

Diagnosis of peripheral artery disease in people with diabetes and a foot ulcer using current non-invasive blood pressure measurements is challenging. Laser speckle contrast imaging (LSCI) is a promising non-invasive technique to measure cutaneous microcirculation. This study investigated the association between microcirculation (measured with both LSCI and non-invasive blood pressure measurement) and healing of diabetic foot ulcers 12 and 26 weeks after measurement. We included sixty-one patients with a diabetic foot ulcer in this prospective, single-center, observational cohort-study. LSCI scans of the foot, ulcer, and ulcer edge were conducted, during baseline and post-occlusion hyperemia. Non-invasive blood pressure measurement included arm, foot, and toe pressures and associated indices. Healing was defined as complete re-epithelialization and scored at 12 and 26 weeks. We found no significant difference between patients with healed or non-healed foot ulcers for both types of measurements (p = 0.135–0.989). ROC curves demonstrated moderate sensitivity (range of 0.636–0.971) and specificity (range of 0.464–0.889), for LSCI and non-invasive blood pressure measurements. Therefore, no association between diabetic foot ulcer healing and LSCI-measured microcirculation or non-invasive blood pressure measurements was found. The healing tendency of diabetic foot ulcers is difficult to predict based on single measurements using current blood pressure measurements or LSCI

Development and reproducibility of a short questionnaire to measure use and usability of custom-made orthopaedic shoes

Objective: To develop a short and easy to use questionnaire to measure use and usability of custom-made orthopaedic shoes, and to investigate its reproducibility.\ud Design: Development of the questionnaire (Monitor Orthopaedic Shoes) was based on a literature search, expert interviews, 2 expert meetings, and exploration and testing of reproducibility. The questionnaire comprises 2 parts: a pre part, measuring expectations; and a post part, measuring experiences.\ud Patients: The pre part of the final version was completed twice by 37 first-time users before delivery of their orthopaedic shoes. The post part of the final version was completed twice by 39 first-time users who had worn their orthopaedic shoes for 2–4 months.\ud Results: High reproducibility scores (Cohen’s kappa > 0.60 or intra class correlation > 0.70) were found in all but one question of both parts of the final version of the Monitor Orthopaedic Shoes questionnaire. The smallest real difference on a visual analogue scale (100 mm) ranged from 21 to 50 mm. It took patients approximately 15 minutes to complete one part.\ud Conclusion: Monitor Orthopaedic Shoes is a practical and reproducible questionnaire that can measure relevant aspects of use and usability of orthopaedic shoes from a patient’s perspective

Should weight-bearing activity be reduced during healing of plantar diabetic foot ulcers, even when using appropriate offloading devices?

Physical activity is an essential part of general health and diabetes management. However, recommending weight-bearing physical activity for people with plantar diabetic foot ulcers is controversial, even when gold standard offloading devices are used, as it is commonly thought to delay healing. We aimed to narratively review relevant studies investigating the relationship between plantar diabetic foot ulcer healing and weight-bearing activity, plantar pressure and device adherence. We defined relevant studies as those from two systematic reviews, along with those identified since using a similar updated Pubmed search strategy. We identified six studies. One study found that more daily steps were associated with worse ulcer healing, three found no significant association between steps and ulcer healing, and in two others the association was unclear. Thus, there is weak evidence for an inverse relationship between weight-bearing physical activity and plantar ulcer healing while utilizing offloading devices. We propose a Diabetic foot Offloading and Activity framework to guide future research to find the optimal balance between the positive and negative effects of weight-bearing activity in the context of foot ulcers. We hope such future studies will shed more conclusive light on the impact of weight-bearing activity on healing of plantar diabetic foot ulcers

Semi-Automatic Tracking of Laser Speckle Contrast Images of Microcirculation in Diabetic Foot Ulcers

Foot ulcers are a severe complication of diabetes mellitus. Assessment of the vascular status of diabetic foot ulcers with Laser Speckle Contrast Imaging (LSCI) is a promising approach for diagnosis and prognosis. However, manual assessment during analysis of LSCI limits clinical applicability. Our aim was to develop and validate a fast and robust tracking algorithm for semi-automatic analysis of LSCI data. The feet of 33 participants with diabetic foot ulcers were recorded with LSCI, including at baseline, during the Post-Occlusive Reactive Hyperemia (PORH) test, and during the Buerger's test. Different regions of interest (ROIs) were used to measure microcirculation in different areas of the foot. A tracking algorithm was developed in MATLAB to reposition the ROIs in the LSCI scans. Manual- and algorithm-tracking of all recordings were compared by calculating the Intraclass Correlation Coefficient (ICC). The algorithm was faster in comparison with the manual approach (90 s vs. 15 min). Agreement between manual- and algorithm-tracking was good to excellent during baseline (ICC = 0.896-0.984; p &lt;0.001), the PORH test (ICC = 0.790-0.960; p &lt;0.001), and the Buerger's test (ICC = 0.851-0.978; p &lt;0.001), resulting in a tracking algorithm that delivers assessment of LSCI in diabetic foot ulcers with results comparable to a labor-intensive manual approach, but with a 10-fold workload reduction.</p

Validity and feasibility of a temperature sensor for measuring use and non-use of orthopaedic footwear

Objective: Adherence is a prerequisite for the effectiveness of orthopaedic footwear. The aim of this study is to assess the validity of a new temperature sensor for objective assessment of footwear use and non-use. Design: Observational study. Methods: The validity of a temperature sensor (Orthotimer, Balingen, Germany) to discriminate between time periods of use and non-use of footwear over a period of 48 h was assessed using 3 algorithms, in 10 healthy participants (mean age 32.8 years (standard deviation (SD) 14.1 years)). Footwear use measured with the sensor was compared with a reference standard, footwear use measured with a time-lapse sports camera secured to the shoe. Main outcome measure: Hours of footwear use. Results: Mean footwear use measured with the camera was 8.10 (SD 2.46) h per day. Mean footwear uses measured with the sensor and calculated with the 3 algorithms were 8.16 (SD 2.37), 8.86 (SD 2.48) and 4.91 (SD 3.17) h per day for the Groningen algorithm, algorithm-25, and algorithm-29, respectively. The correlation between footwear use assessed with the camera and with the sensor was: r(Groningen) = 0.995, r(alg25) = 0.919 and r(alg29) = 0.680). Conclusion: The temperature sensor is a valid instrument to measure footwear use and non-use when using the Groningen algorithm

Standards for the development and methodology of the 2019 International Working Group on the Diabetic Foot guidelines

Diabetic foot disease is a source of major patient suffering and societal costs. Investing in evidence-based international guidelines on diabetic foot disease is likely among the most cost-effective forms of health care expenditure, provided the guidelines are outcome focused, evidence based, and properly implemented. The International Working Group on the Diabetic Foot (IWGDF) has published and updated international guidelines since 1999. The 2019 updates are based on formulating relevant clinical questions and outcomes, rigorous systematic reviews of the literature, and recommendations that are specific, and unambiguous along with their transparent rationale, all using the Grading of Recommendations Assessment Development and Evaluation (GRADE) framework. We herein describe the development of the 2019 IWGDF guidelines on the prevention and management of diabetic foot disease, which consists of six chapters, each prepared by a separate working group of international experts. These documents provide guidelines related to diabetic foot disease on prevention; offloading; peripheral artery disease; infection; wound healing interventions; and classification of diabetic foot ulcers. Based on these six chapters, the IWGDF Editorial Board also produced a set of practical guidelines. Each guideline underwent extensive review by the members of the IWGDF Editorial Board as well as independent international experts in each field. We believe that adoption and implementation of the 2019 IWGDF guidelines by health care providers, public health agencies, and policymakers will result in improved prevention and management of diabetic foot disease and a subsequent worldwide reduction in the patient and societal burden this disease causes