Assessment of bone marrow edema on dual-energy CT scans in people with diabetes mellitus and suspected Charcot neuro-osteoarthropathy.

OBJECTIVE: This study aimed to quantitatively assess the diagnostic value of bone marrow edema (BME) detection on virtual non-calcium (VNCa) images calculated from dual-energy CT (DECT) in people with diabetes mellitus and suspected Charcot neuro-osteoarthropathy (CN). MATERIALS AND METHODS: People with diabetes mellitus and suspected CN who underwent DECT of the feet (80kVp/Sn150kVp) were included retrospectively. Two blinded observers independently measured CT values on VNCa images using circular regions of interest in five locations in the midfoot (cuneiforms, cuboid and navicular) and the calcaneus of the contralateral or (if one foot was available) the ipsilateral foot. Two clinical groups were formed, one with active CN and one without active CN (no-CN), based on the clinical diagnosis. RESULTS: Thirty-two people with diabetes mellitus and suspected CN were included. Eleven had clinically active CN. The mean CT value in the midfoot was significantly higher in the CN group (-55.6 ± 18.7 HU) compared to the no-CN group (-94.4 ± 23.5 HU; p < 0.001). In the CN group, the difference in CT value between the midfoot and calcaneus was statistically significant (p = 0.003); this was not the case in the no-CN group (p = 0.357). The overall observer agreement was good for the midfoot (ICC = 0.804) and moderate for the calcaneus (ICC = 0.712). Sensitivity was 100.0% and specificity was 71.4% using a cutoff value of -87.6 HU. CONCLUSION: The detection of BME on VNCa images has a potential value in people with diabetes mellitus and suspected active CN.

Adherence and Wearing Time of Prescribed Footwear among People at Risk of Diabetes-Related Foot Ulcers: Which Measure to Use?

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.

Biomechanical and musculoskeletal changes after flexor tenotomy to reduce the risk of diabetic neuropathic toe ulcer recurrence.

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 < 0.001). Metatarsophalangeal, proximal interphalangeal and distal interphalangeal joint angles were assessed on nine toes and all decreased significantly (by 7° [95% CI: 4-9; p < 0.001], 19° [95% CI: 11-26; p < 0.001] and 28° [95% CI: 13-44; p = 0.003], respectively). CONCLUSION: These observations show a beneficial effect of flexor tenotomy on biomechanical and musculoskeletal outcomes in the toes, without ulcer recurrence.

An integrated personalized assistive devices approach to reduce the risk of foot ulcer recurrence in diabetes (DIASSIST): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Preventing foot ulcers in people with diabetes can increase quality of life and reduce costs. Despite the availability of various interventions to prevent foot ulcers, recurrence rates remain high. We hypothesize that a multimodal treatment approach incorporating various footwear, self-management, and education interventions that matches an individual person's needs can reduce the risk of ulcer recurrence with beneficial cost-utility. The aim of this study is to assess the effect on foot ulcer recurrence, footwear adherence, and cost-utility of an integrated personalized assistive devices approach in high-risk people with diabetes. METHODS: In a parallel-group multicenter randomized controlled trial, 126 adult participants with diabetes mellitus type 1 or 2, loss of protective sensation based on the presence of peripheral neuropathy, a healed plantar foot ulcer in the preceding 4 years, and possession of any type of custom-made footwear will be included. Participants will be randomly assigned to either enhanced therapy or usual care. Enhanced therapy consists of usual care and additionally a personalized treatment approach including pressure-optimized custom-made footwear, pressure-optimized custom-made footwear for indoor use, at-home daily foot temperature monitoring, and structured education, which includes motivational interviewing and personalized feedback on adherence and self-care. Participants will be followed for 12 months. Assessments include barefoot and in-shoe plantar pressure measurements; questionnaires concerning quality of life, costs, disease, and self-care knowledge; physical activity and footwear use monitoring; and clinical monitoring for foot ulcer outcomes. The study is powered for 3 primary outcomes: foot ulcer recurrence, footwear adherence, and cost-utility, the primary clinical, patient-related, and health-economic outcome respectively. DISCUSSION: This is the first study to integrate multiple interventions for ulcer prevention into a personalized state-of-the-art treatment approach and assess their combined efficacy in a randomized controlled trial in people with diabetes at high ulcer risk. Proven effectiveness, usability, and cost-utility will facilitate implementation in healthcare, improve the quality of life of high-risk people with diabetes, and reduce treatment costs. TRIAL REGISTRATION: ClinicalTrials.gov NCT05236660. Registered on 11 February 2022.

Custom-made footwear designed for indoor use increases short-term and long-term adherence in people with diabetes at high ulcer risk.

INTRODUCTION: To 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 METHODS: Adherence 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 (<80%) baseline indoor adherence; secondary group: participants with high (≥80%) baseline indoor adherence. Peak plantar pressures of the indoor footwear were compared with the regular custom-made footwear. Footwear usability was evaluated at 3 months via a questionnaire. At 12 months, ulcer recurrence was assessed through participant/prescriber reporting. RESULTS: Of 31 participants, 23 had low baseline indoor adherence (<80%). Overall adherence in this group increased statistically significant from median 65% (IQR: 56%-72%) at baseline to 77% (60%-89%) at 1 month (p=0.002) and 87% (60%-93%) at 12 months (p<0.001). This was due to a significant increase in adherence indoors: baseline: 48% (21%-63%); 1 month: 71% (50%-83%) (p=0.001); and 12 months: 77% (40%-91%) (p<0.001). Mean peak plantar pressures were comparable between the indoor and regular custom-made footwear. Participants were positive about usability. One-year ulcer recurrence rate was 26%. CONCLUSIONS: Footwear 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.

Users' needs and expectations and the design of a new custom-made indoor footwear solution for people with diabetes at risk of foot ulceration.

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 rehabilitationPeople 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.

Health-related quality of life and associated factors in people with diabetes at high risk of foot ulceration.

BACKGROUND: The health-related quality of life (HRQoL) of people with diabetes-related foot complications has been increasingly reported, mostly from studies of people with a foot ulcer. The aim of this study was to assess HRQoL and determine factors associated with HRQoL in people with diabetes at high risk of foot ulceration. METHODS: In all, 304 participants enrolled in the Diabetic Foot Temperature Trial (DIATEMP) were included in the cross-sectional analysis. HRQoL was measured by the RAND® 36-Item Short Form Health Survey (SF-36) at baseline. Potential factors associated with HRQoL were analysed using multiple linear regression analyses for the eight domains of the SF-36. RESULTS: Participants were predominantly male (72%), mean age 64.6 (±10.5) years, 77% type 2 diabetes and mean duration of diabetes 20 (±14) years. Mean SF-36 domain scores for the General Health (49.2 ± 20.1), Role Physical (50.9 ± 44.7), Physical Function (58.5 ± 27.9) and Vitality domains (59.8 ± 21.6) were lower compared to the Mental Health (78.4 ± 18.0), Social Functioning (75.3 ± 24.2), Role Emotional (73.5 ± 38.9) and Bodily Pain (67.0 ± 27.0) domains. HRQoL was lower than Dutch population-based and general diabetes samples, but higher than in samples with an ulcer. Use of a walking aid was associated with lower HRQoL across all 8 SF-36 domains (ß range - 0.20 to - 0.50), non-Caucasian descent was associated with lower HRQoL in 5 domains (ß range - 0.13 to - 0.17). Not working, higher BMI and younger age were associated with lower HRQoL in 3 domains. CONCLUSIONS: People at high risk of diabetes-related foot ulceration have reduced HRQoL that varies across domains, with the physical domains most affected. Assessing mobility, ethnicity, BMI and job status may be useful in daily practice to screen for people who might benefit from interventions targeting HRQoL. TRIAL REGISTRATION: Netherlands Trial Registration: NTR5403. Registered on 8 September 2015.

[Percutaneous needle flexor tendon tenotomy to prevent diabetic foot ulcers]. / Percutane flexorpeestenotomie met een naald.

People with diabetes and polyneuropathy often develop foot deformities, resulting in ulcers or pre-ulcerative lesions on the apex of the toes. The Dutch guideline on diabetic foot disease recommends considering a flexor tendon tenotomy to treat a distal toe ulcer, if conservative treatment fails, and to prevent a toe ulcer if a pre-ulcerative lesion is present. To our knowledge, this technique is rarely performed in the Netherlands and if used, performed with a scalpel. Recent studies show that a new, less invasive technique, the needle flexor tenotomy, is relatively safe and effective. The purpose of this procedure is reducing mechanical pressure. However, this has not yet been quantitatively demonstrated. We regularly apply this new surgical technique, including functional assessment by means of dynamic barefoot pressure measurements. We bring this surgical technique and its biomechanical effect to your attention in this article, as an effective and easy to implement intervention.

Effectiveness of at-home skin temperature monitoring in reducing the incidence of foot ulcer recurrence in people with diabetes: a multicenter randomized controlled trial (DIATEMP).

INTRODUCTION: The 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 METHODS: In 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 (<4 years, n=295), or Charcot's neuro-arthropathy (n=9) to usual care (ie, podiatric treatment, education, and therapeutic footwear) or usual care plus measuring skin temperatures at 6-8 plantar sites per foot each day (enhanced therapy). If ∆T>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. RESULTS: On 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). CONCLUSIONS: At-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 NUMBER: NTR5403.

Neuro-osteoarthropathy of the foot-radiologist: friend or foe?

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.

An Explorative Study on the Efficacy and Feasibility of the Use of Motivational Interviewing to Improve Footwear Adherence in Persons with Diabetes at High Risk for Foot Ulceration.

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, <80% of steps taken in prescription footwear) were randomly assigned to standard education (ie, verbal and written instructions) or to standard education plus two 45-min sessions of motivational interviewing. Adherence was objectively measured over 7 days using ankle- and shoe-worn sensors and was calculated as the percentage of total steps that prescribed footwear was worn. Adherence was assessed at home and away from home at baseline and 1 week and 3 months after the intervention. Feasibility was assessed for interviewer proficiency to apply motivational interviewing and for protocol executability. 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.

The cost-effectiveness and cost-utility of at-home infrared temperature monitoring in reducing the incidence of foot ulcer recurrence in patients with diabetes (DIATEMP): study protocol for a randomized controlled trial.

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: Netherlands Trial Registration: NTR5403 . Registered on 8 September 2015.

The use and safety of combined resistance and aerobic training in a patient with complications related to type 2 diabetes: a case report.

PURPOSE: 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. CASE DESCRIPTION: 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. OUTCOMES: 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. CONCLUSION: 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. [ IMPLICATIONS FOR REHABILITATION: • 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.]

Evaluation and optimization of therapeutic footwear for neuropathic diabetic foot patients using in-shoe plantar pressure analysis.

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.

Assessment of physical activity in people with diabetes and peripheral neuropathy.

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.