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Purpose: To assess users’ needs and expectations regarding custom-made indoor footwear, and to design such footwear with similar biomechanical efficacy and better usability compared to regular custom-made footwear in people with diabetes at risk for foot ulceration. Materials and methods: Multidisciplinary systematic design approach. Needs and expectations regarding indoor footwear were evaluated via a questionnaire in 50 high foot ulcer risk people with diabetes using custom-made footwear. We systematically designed indoor footwear, and manufactured this for nine participants. Primary requirement was similar plantar pressure compared to participants’ regular custom-made footwear. Results: Eighty-two percent of participants expressed a need for custom-made indoor footwear and 66% expected such footwear to increase their adherence. The custom-made indoor footwear had the same bottom construction as participants’ regular custom-made footwear, but with softer and more light-weight upper materials. Peak pressures were similar or lower, while qualitative evaluation showed better usability and lower costs for indoor footwear. Conclusions: People with diabetes at risk of foot ulceration expressed a clear need for custom-made indoor footwear, and expected such footwear to increase their adherence. Our indoor footwear design provides adequate pressure relief, with better usability, and can be produced at lower costs compared to regular custom-made footwear.Implications for rehabilitation People with diabetes at risk of foot ulceration express a need for special indoor footwear. We developed indoor footwear with similar offloading capacity as regular custom-made footwear. The indoor footwear is lighter in weight, easier to don/doff and lower in costs. At-risk people with diabetes expect this footwear to increase their footwear adherence.

IntroductionTo explore changes in footwear adherence following provision of custom-made indoor footwear in people with diabetes at high risk for plantar foot ulceration and in possession of regular custom-made footwear.Research design and methodsAdherence indoors and outdoors was assessed objectively as percentage of steps custom-made footwear was worn, at baseline (in regular custom-made footwear), and at 1 and 12 months after providing custom-made indoor footwear (in both indoor and regular footwear). Primary group: participants with low (ResultsOf 31 participants, 23 had low baseline indoor adherence (ConclusionsFootwear adherence increased in the short-term and long-term after provision of custom-made indoor footwear in people at high risk of diabetic foot ulceration with low baseline adherence, because they actively wore their newly provided indoor footwear inside their house. Footwear adherence may be helped by using both regular and indoor custom-made footwear in clinical practice; the effect on ulcer recurrence should be investigated in future trials.

IntroductionThe skin of people with diabetic foot disease is thought to heat up from ambulatory activity before it breaks down into ulceration. This allows for early recognition of imminent ulcers. We assessed whether at-home monitoring of plantar foot skin temperature can help prevent ulcer recurrence in diabetes.Research design and methodsIn this parallel-group outcome-assessor-blinded multicenter randomized controlled trial (7 hospitals, 4 podiatry practices), we randomly assigned people with diabetes, neuropathy, foot ulcer history (2.2°C between corresponding sites on the left and right foot for two consecutive days, participants were instructed to reduce ambulatory activity until this hotspot disappeared and contact their podiatrist. Primary outcome was ulcer recurrence in 18 months on the plantar foot, interdigital, or medial/lateral/anterior forefoot surfaces; secondary outcome was ulcer recurrence at any foot site.ResultsOn the basis of intention-to-treat, 44 of 151 (29.1%) participants in enhanced therapy and 57 of 153 (37.3%) in usual care had ulcer recurrence at a primary outcome site (RR: 0.782 (95%CI 0.566 to 1.080), p=0.133). Of the 83 participants in enhanced therapy who measured a hotspot, the 24 subsequently reducing their ambulatory activity had significantly fewer ulcer recurrences (n=3) than those in usual care (RR: 0.336 (95% CI 0.114 to 0.986), p=0.017). Enhanced therapy was effective over usual care for ulcer recurrence at any foot site (RR: 0.760 (95% CI 0.579 to 0.997), p=0.046).ConclusionsAt-home foot temperature monitoring does not significantly reduce incidence of diabetic foot ulcer recurrence at or adjacent to measurement sites over usual care, unless participants reduce ambulatory activity when hotspots are found, or when aiming to prevent ulcers at any foot site.Trial registration numberNTR5403.

Aims To investigate people with Charcot midfoot deformity with regard to plantar pressure, footwear adherence and plantar foot ulcer recurrence. Methods Twenty people with diabetes, Charcot midfoot deformity, plantar foot ulcer history and custom‐made footwear were assessed with regard to barefoot and in‐shoe plantar pressures during walking, footwear adherence (% of daily steps over 7‐day period) and plantar foot ulcer recurrence over 18 months. In a cohort design, they were compared to 118 people without Charcot foot (non‐Charcot foot group) with custom‐made footwear and similar ulcer risk factors. Results Median (interquartile range) barefoot midfoot peak pressures were significantly higher in the Charcot foot group than in the non‐Charcot foot group [756 (260–1267) vs 146 (100–208) kPa; P

Objective: To assess the effect of flexor tenotomy in patients with diabetes on barefoot plantar pressure, toe joint angles and ulcer recurrence during patient follow-up. Methods: Patients with a history of ulceration on the toe apex were included. They underwent minimally invasive needle flexor tenotomy by an experienced musculoskeletal surgeon. Dynamic barefoot plantar pressure measurements and static weight-bearing radiographs were taken before and 2–4 weeks after the procedure. Results: A total of 14 patients underwent flexor tenotomy on 50 toes in 19 feet. There was a mean follow-up time of 11.4 months. No ulcer recurrence occurred during follow-up. Mean barefoot plantar pressure was assessed on 34 toes and decreased significantly after the procedure by a mean 279 kPa (95% CI: 204–353; p

Background:In this explorative study, we assessed the effect and feasibility of using motivational interviewing to improve footwear adherence in persons with diabetes who are at high risk for foot ulceration and show low adherence to wearing prescribed custom-made footwear.Methods:Thirteen individuals with diabetes, ulcer history, and low footwear adherence (ie, Results:Median (range) baseline, 1-week, and 3-month adherence at home was 49% (6%–63%), 84% (5%–98%), and 40% (4%–80%), respectively, in the motivational interviewing group and 35% (13%–64%), 33% (15%–55%), and 31% (3%–66%), respectively, in the standard education group. Baseline, 1-week, and 3-month adherence away from home was 91% (79%–100%), 97% (62%–99%) and 92% (86%–98%), respectively, in the motivational interviewing group and 78% (32%–97%), 91% (28%–98%), and 93% (57%–100%), respectively, in the standard education group. None of the differences were statistically significant. Interviewer proficiency was good, and the protocol could be successfully executed in the given time frame.Conclusions:Footwear adherence at home increases 1 week after motivational interviewing to clinically relevant but not statistically significant levels (ie, 80%) but then returns over time to baseline levels. Away from home, adherence is already sufficient at baseline and remains so over time. The use of motivational interviewing seems feasible for the given purpose and patient group. These findings provide input to larger trials and provisionally suggest that additional or adjunctive therapy may be needed to better preserve adherence.

Adherence to wearing custom-made footwear is a known problem in people with diabetes who are at high risk of foot ulceration, especially indoors (Waaijman et al., 2013). Footwear that is specifical...

Supported by evidence‐based guidelines, custom‐made footwear is often prescribed to people with diabetes who are at risk for ulceration. However, these guidelines do not specify the footwear design features, despite available scientific evidence for these features. We aimed to develop a design protocol to support custom‐made footwear prescription for people with diabetes and peripheral neuropathy. The population of interest was people with diabetes who are at moderate‐to‐high risk of developing a foot ulcer, for whom custom‐made footwear (shoes and/or insoles) can be prescribed. A group of experts from rehabilitation medicine, orthopaedic shoe technology (pedorthics) and diabetic foot research, reviewed the scientific literature and met during 12 face‐to‐face meetings to develop a footwear design algorithm and evidence‐based pressure‐relief algorithm as parts of the protocol. Consensus was reached where evidence was not available. Fourteen domains of foot pathology in combination with loss of protective sensation were specified for the footwear design algorithm and for each domain shoe‐specific and insole (orthosis)‐specific features were defined. Most insole‐related features and some shoe‐related features were evidence based, whereas most shoe‐related features were consensus based. The pressure‐relief algorithm was evidence based using recent footwear trial data and specifically targeted patients with a healed plantar foot ulcer. These footwear design and pressure‐relief algorithms are the first of their kind and should facilitate more uniform decision making in the prescription and manufacturing of adequate shoes for moderate‐to‐high‐risk patients, reducing variation in footwear provision and improving clinical outcome in the prevention of diabetic foot ulcers.

Home monitoring of foot temperatures in high-risk diabetes patients proves to be a promising approach for early recognition and treatment of pre-signs of ulceration, and thereby ulcer prevention. Despite previous studies demonstrating its efficacy, it is currently not widely applied in (Dutch) health care. In a multicenter, outcome-assessor-blinded, randomized controlled trial, 304 patients with diabetes mellitus types I or II, loss of protective sensation based on peripheral neuropathy, and a history of foot ulceration in the preceding 4 years or a diagnosis of Charcot neuro-osteoarthropathy will be included. Enhanced therapy will consist of usual care and additional at-home daily measurement of foot temperatures at six to eight predefined locations on the foot. If a contralateral foot temperature difference of > 2.2 °C is found on two consecutive days, the participant is instructed to contact their podiatrist for further foot diagnosis or treatment, and to reduce ambulatory activity by 50% until temperatures are normalized. Enhanced therapy will be compared to usual care. The primary outcomes are the cost (savings) per patient without a foot ulcer (i.e., cost-effectiveness) and per quality-adjusted life year gained (i.e., cost-utility). The primary clinical outcome in the study is the proportion of patients with foot ulcer recurrence on the plantar foot, apical surfaces of the toes, the interdigital spaces or medial and lateral forefoot surfaces during 18-month follow-up. Confirmation of the efficacy of at-home foot temperature monitoring in ulcer prevention, together with assessing its usability, cost-effectiveness and cost-utility, could lead to implementation in Dutch health care, and in many settings across the world. Netherlands Trial Registration: NTR5403 . Registered on 8 September 2015.

OBJECTIVE Custom-made footwear is the treatment of choice to prevent foot ulcer recurrence in diabetes. This footwear primarily aims to offload plantar regions at high ulcer risk. However, ulcer recurrence rates are high. We assessed the effect of offloading-improved custom-made footwear and the role of footwear adherence on plantar foot ulcer recurrence. RESEARCH DESIGN AND METHODS We randomly assigned 171 neuropathic diabetic patients with a recently healed plantar foot ulcer to custom-made footwear with improved and subsequently preserved offloading (∼20% peak pressure relief by modifying the footwear) or to usual care (i.e., nonimproved custom-made footwear). Primary outcome was plantar foot ulcer recurrence in 18 months. Secondary outcome was ulcer recurrence in patients with an objectively measured adherence of ≥80% of steps taken. RESULTS On the basis of intention-to-treat, 33 of 85 patients (38.8%) with improved footwear and 38 of 86 patients (44.2%) with usual care had a recurrent ulcer (relative risk −11%, odds ratio 0.80 [95% CI 0.44–1.47], P = 0.48). Ulcer-free survival curves were not significantly different between groups (P = 0.40). In the 79 patients (46% of total group) with high adherence, 9 of 35 (25.7%) with improved footwear and 21 of 44 (47.8%) with usual care had a recurrent ulcer (relative risk −46%, odds ratio 0.38 [0.15–0.99], P = 0.045). CONCLUSIONS Offloading-improved custom-made footwear does not significantly reduce the incidence of plantar foot ulcer recurrence in diabetes compared with custom-made footwear that does not undergo such improvement, unless it is worn as recommended.

Diabet. Med. 29, 1542–1549 (2012) Abstract Aims To assess the value of using in-shoe plantar pressure analysis to improve and preserve the offloading properties of custom-made footwear in patients with diabetes. Methods Dynamic in-shoe plantar pressures were measured in new custom-made footwear of 117 patients with diabetes, neuropathy, and a healed plantar foot ulcer. In 85 of these patients, high peak pressure locations (peak pressure > 200 kPa) were targeted for pressure reduction (goal: > 25% relief or below an absolute level of 200 kPa) by modifying the footwear. After each of a maximum three rounds of modifications, pressures were measured. In a subgroup of 32 patients, pressures were measured and, if needed, footwear was modified at 3-monthly visits for 1 year. Pressures were compared with those measured in 32 control patients who had no footwear modifications based on pressure analysis. Results At the previous ulcer location and the highest and second highest pressure locations, peak pressures were significantly reduced by 23%, 21% and 15%, respectively, after modification of footwear. These lowered pressures were maintained or further reduced over time and were significantly lower, by 24–28%, compared with pressures in the control group. Conclusion The offloading capacity of custom-made footwear for high-risk patients can be effectively improved and preserved using in-shoe plantar pressure analysis as guidance tool for footwear modification. This provides a useful approach to obtain better offloading footwear that may reduce the risk for pressure-related diabetic foot ulcers.

No guidelines for tailoring exercise programs for patients with diabetic complications are available. The purpose of this case report is to report our experiences with a tailored exercise program including safety precautions for a patient with complications related to type 2 diabetes and exercise related regulation issues.A patient with multiple diabetic complications, poor glycemic control, and a history of foot ulceration participated in a 12-week exercise program with multiple safety precautions.Hypoglycemic events required adjustments in training intensity and insulin dosage. Periodic foot screening revealed no ulceration. Target training intensity was achieved at the end of the program, although exercise load could not be increased according to the planned protocol. Training effects were observed in muscle strength increased, perceived limitations in daily functioning diminished and no change in sub maximal exercise capacity.This patient with severe diabetic complications participated safely and successfully in an exercise program. Problems with glycemic control occurred but did not preclude adherence to incremental exercise. We recommend a medical screening, the availability of a network of specialists, and a physical therapist with sufficient knowledge of diabetic complications and exercise physiology to guide training in this patient population. [• This case report demonstrates that physical functioning can be improved safely in a patient with multiple diabetic complications.• For safety precautions, a medical screening including a X-ECG and a foot screen prior to exercise, and the involvement of a diabetes specialist nurse, a podiatrist, an endocrinologist and a physiatrist in the rehabilitation team are recommended.• Sufficient knowledge of diabetic complications and exercise physiology is needed in supervising exercise programs for patients with multiple diabetic complications.]

Charcot neuro-osteoarthropathy is a rare condition that affects subjects with diabetes with neuropathy (1). Although the underlying pathophysiology is largely unknown, increased receptor activator of nuclear factor κ-B ligand (RANKL) activation in Charcot neuro-osteoarthropathy has been observed (2). As monoclonal RANKL antibody treatment (denosumab, Prolia) reduces osteoporosis-related fractures (3), we studied its effect on fracture resolution time and clinical outcomes in acute Charcot neuro-osteoarthropathy. All patients with diabetes seen at our foot clinic between 2012 and 2016 were categorized by modified Brodsky classification (4) and treated according to a standardized total contact cast (TCC) protocol. This comprises weekly TCC changes and subsequent conventional X-ray imaging every 4 weeks, as well as supplementation daily with calcium 500 mg/cholecalciferol 800 IE to achieve adequate plasma calcium (between 2.2 and 2.5 mmol/L) and vitamin D levels …

Diabet. Med. 28, 212–217 (2011) Abstract Aims To investigate the feasibility and preliminary effectiveness of an exercise programme for patients with diabetic complications. Methods In this pre-post design study, 22 patients from a diabetic foot outpatient clinic participated in a 12-week individualized exercise programme, consisting of aerobic and resistance exercise, with specific safety precautions. Feasibility was assessed on the basis of programme adherence, adverse events, achievement of the target training intensity and patient satisfaction. Preliminary effectiveness was evaluated with pre-post-changes in blood glucose regulation (HbA1c), muscle strength (isometric peak torque) and perceived limitations in functioning (Patient Specific Function Scale with visual analogue scale). Results Twenty patients completed the exercise programme with a high mean attendance (85%). No training-related severe adverse events occurred. The target training intensity was achieved by 70% of the participants. Patient satisfaction was high. HbA1c decreased from 8.2% before to 7.8% after the programme (P = 0.005), muscle strength increased from 136.4 to 150.4 Nm (P = 0.046) and perceived limitations in functioning decreased from 7.2 to 5.8 mm (P = 0.003). Conclusions The prescribed exercise programme had a potentially positive effect on blood glucose regulation, muscle strength and perceived limitations in functioning in patients with diabetic complications.

OBJECTIVE Therapeutic footwear for diabetic foot patients aims to reduce the risk of ulceration by relieving mechanical pressure on the foot. However, footwear efficacy is generally not assessed in clinical practice. The purpose of this study was to assess the value of in-shoe plantar pressure analysis to evaluate and optimize the pressure-reducing effects of diabetic therapeutic footwear. RESEARCH DESIGN AND METHODS Dynamic in-shoe plantar pressure distribution was measured in 23 neuropathic diabetic foot patients wearing fully customized footwear. Regions of interest (with peak pressure >200 kPa) were selected and targeted for pressure optimization by modifying the shoe or insole. After each of a maximum of three rounds of modifications, the effect on in-shoe plantar pressure was measured. Successful optimization was achieved with a peak pressure reduction of >25% (criterion A) or below an absolute level of 200 kPa (criterion B). RESULTS In 35 defined regions, mean peak pressure was significantly reduced from 303 (SD 77) to 208 (46) kPa after an average 1.6 rounds of footwear modifications (P < 0.001). This result constitutes a 30.2% pressure relief (range 18–50% across regions). All regions were successfully optimized: 16 according to criterion A, 7 to criterion B, and 12 to criterion A and B. Footwear optimization lasted on average 53 min. CONCLUSIONS These findings suggest that in-shoe plantar pressure analysis is an effective and efficient tool to evaluate and guide footwear modifications that significantly reduce pressure in the neuropathic diabetic foot. This result provides an objective approach to instantly improve footwear quality, which should reduce the risk for pressure-related plantar foot ulcers.

This study evaluates the validity of the Step Activity Monitor (SAM) for assessing physical activity in neuropathic people with diabetes and the relation with self-reported physical activity. SAM was shown to be valid. Although SAM and self-reported physical activity are correlated, caution should be taken with self-reported data when monitoring individuals.

Charcot neuro-osteoarthropathy is a significant problem with a rapid devastating nature. If not recognized it may lead to progressive foot deformity, ulceration or osteomyelitis, or eventually to amputation. The diagnosis is challenging, and imaging plays a pivotal role. Rapid and accurate diagnosis and early intervention is important to prevent progressive and destructive Charcot deformity of the foot. The imaging workup of the warm swollen Charcot foot is presented. The advantages and disadvantages of different imaging modalities are discussed. This review provides the consulting radiologists with tools to cautiously differentiate Charcot's neuro-osteoarthropathy from osteomyelitis. It is crucial to look beyond radiological features and integrate the location of pathology and presence of ulcer in the reading process. Because imaging plays a pivotal role in arriving at the definitive diagnosis and adequate treatment, the radiologist "makes the difference"-can be a friend or a foe.

The aim of this study was to assess the effectiveness of custom-made footwear, of which offloading is improved based on in-shoe plantar pressure analysis, in preventing plantar foot ulcer recurrence in high-risk diabetic patients.

Background Diabetic patients at high risk for foot ulceration are often prescribed with custom-made therapeutic footwear. However, the evidence base to support the use of this footwear for ulcer prevention is still meagre [1]. The lack of offloading efficacy may play a role in this. In-shoe plantar pressure assessment is a valuable tool for evaluating footwear and guiding modifications to optimize the footwear’s offloading properties [2]. The aim of this multicenter randomized trial was to assess the effectiveness of this approach and long-term pressure monitoring in prescription footwear to prevent plantar foot ulcer recurrence in neuropathic diabetic patients.

The golden standard for a radiological diagnosis of an underlying osteomyelitis in a diabetic foot ulcer is lacking. Recent meta-analyse showed that a plain X ray had a sensitivity of 0.54 and a specificity of 0.68. MRI had a pooled sensitivity of 0.9 and a specificity of 0.79, but these numbers decreased to respectively 0.83 and 0.4 for detection of osteomyelitis in the mid and hind foot. The aim of our study was to examine the positive and negative predictive value and sensitivity and specificity of plain X ray in a diabetic foot ulcer.

In 2008 we examined retrospectively the prevalence of clindamycin resistant Staphylococcus aureus (CRSA) in the outpatient diabetic foot clinic. The prevalence of CRSA was 48.5 %. The first line broad spectrum antibiotic regimen for diabetic ulcer with underlying osteomyelitis was changed from clindamycin plus ciprofloxacin to flucloxacillin plus ciprofloxacin. The aim of the study was to examine the prevalence of CRSA in 2009 and 2010.