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The incidence of diabetes is increasing worldwide with concomitant raising number of patients with diabetic foot disease. Diabetic foot disease treatment has received more attention in the past decades, culminating in the creation of multidisciplinary outpatient clinics, but at the same time, complexity of patients seems to have increased. The aim of this article is to study differences in patient characteristics and outcomes (ulcer healing and ulcer-free survival days) in patients with a diabetic foot ulcer in two prospective cohorts with 15 years in between. Prospective cohort study of all patients in one diabetic foot centre of expertise in 2003-2004 and 2014-2018. Clinical outcomes were determined after a follow-up period of 12 months. Outcomes were differences in baseline characteristics and comorbidities, and differences in ulcer-related outcomes between both cohorts. We included all consecutive diabetic foot ulcer patients from our centre for the period 2003-2004 (n = 79) and 2014-2018 (n = 271). Age (67.0 +/- 14.3 vs. 71.6 +/- 11.5, p = 0.003) and prevalence of end-stage renal disease (1.3% vs. 7.7%, p = 0.036) were significantly higher in the more recent population. The more recent population had higher healing rate (53.2% vs. 76.4%, p < 0.001), higher median ulcer-free survival days once an ulcer had healed [173 days (IQR 85.3-295.5) vs. 257.0 (IQR 157.0-318.0), p = 0.026], and fewer minor amputations (20.3% vs. 8.1%, p = 0.002). People with diabetic foot ulcers treated in 2014-2018 were older and more frequently diagnosed with ESRD, compared to this population in 2003-2004, while other characteristics were similar; ulcer-related outcomes were better.

Objective: Diabetic foot ulcers (DFUs) are mostly cured by an off-loading cast. Healing ratios of a non-removable Total Contact Softcast (TCS) were compared to a conventional Total Contact Cast (TCC), the latter reporting negative effects on lifestyle and transportation.Methods: Analysis of prospectively collected data for 2010–2017. Included were patients with a neuropathic DFU. Ischemic ulcers were excluded, as were Charcot arthropathy, non-plantar/non-forefoot ulcer location, and compliance issues. Patients with TCS were compared to TCC. Primary and secondary outcomes were healing ratio and healing time of DFU.Results: 50 patients with 61 cast periods were included. Mean age was 63.7 ± 10.1 years. Overall successful ulcer healing was 71% (43/61). Except for depth of the DFUs, between-group patient characteristics were comparable; deeper DFUs were reported in the TCC group. This group reported 65% healed DFU (22/34), the TCS group 74% (20/27). Mean healing time was 8.4 weeks (95 %CI 5.9–10.8) for TCC and 5.5 weeks (95 %CI 4.2–6.9) for TCS (p = 0.052). Depth of the wound was a confounder.Conclusions: TCS had a similar DFU healing ratio and a potentially clinically relevant effect (HR 1.47, 95 %CI 0.64–3.38) on healing time (ns). Ulcer depth is important for time to ulcer healing. A randomized study is recommended.

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&rsquo, 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&ndash, 0.984, p &lt, 0.001), the PORH test (ICC = 0.790&ndash, 0.960, 0.001), and the Buerger&rsquo, s test (ICC = 0.851&ndash, 0.978, 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.

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.

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.

Background: Thermal assessment of the plantar surface of the foot using spot thermometers and thermal imaging has been proven effective in diabetic foot ulcer prevention. However, with traditional cameras this is limited to single spots or a two-dimensional (2D) view of the plantar side of foot, where only 50% of the ulcers occur. To improve ulcer detection, the view has to be extended beyond 2D. Our aim is to explore for proof of concept the combination of three-dimensional (3D) models with thermal imaging for inflammation detection in diabetic foot disease. Method: From eight participants with a current diabetic foot ulcer we simultaneously acquired a 3D foot model and three thermal infrared images using a high-resolution medical 3D imaging system aligned with three smartphone-based thermal infrared cameras. Using spatial transformations, we aimed to map thermal images onto the 3D model, to create the 3D visualizations. Expert clinicians assessed these for quality and face validity as +, +/-, -. Results: We could replace the texture maps (color definitions) of the 3D model with the thermal infrared images and created the first-ever 3D thermographs of the diabetic foot. We then converted these models to 3D PDF-files compatible with the hospital IT environment. Face validity was assessed as + in six and +/- in two cases. Conclusions: We have provided a proof of concept for the creation of clinically useful 3D thermal foot images to assess the diabetic foot skin temperature in 3D in a hospital IT environment. Future developments are expected to improve the image-processing techniques to result in easier, handheld applications and driving further research.

IntroductionWe aimed to develop a prediction model for foot ulcer recurrence in people with diabetes using easy-to-obtain clinical variables and to validate its predictive performance in order to help risk assessment in this high-risk group.Research design and methodsWe used data from a prospective analysis of 304 people with foot ulcer history who had 18-month follow-up for ulcer outcome. Demographic, disease-related and organization-of-care variables were included as potential predictors. Two logistic regression prediction models were created: model 1 for all recurrent foot ulcers (n=126 events) and model 2 for recurrent plantar foot ulcers (n=70 events). We used 10-fold cross-validation, each including five multiple imputation sets for internal validation. Performance was assessed in terms of discrimination using area under the receiver operating characteristic curve (AUC) (0–1, 1=perfect discrimination), and calibration with the Brier Score (0–1, 0=complete concordance predicted vs observed values) and calibration graphs.ResultsPredictors in model 1 were: a younger age, more severe peripheral sensory neuropathy, fewer months since healing of previous ulcer, presence of a minor lesion, use of a walking aid and not monitoring foot temperatures at home. Mean AUC for model 1 was 0.69 (2SD 0.040) and mean Brier Score was 0.22 (2SD 0.011). Predictors in model 2 were: a younger age, plantar location of previous ulcer, fewer months since healing of previous ulcer, presence of a minor lesion, consumption of alcohol, use of a walking aid, and foot care received in a university medical center. Mean AUC for model 2 was 0.66 (2SD 0.023) and mean Brier Score was 0.16 (2SD 0.0048).ConclusionsThese internally validated prediction models predict with reasonable to good calibration and fair discrimination who is at highest risk of ulcer recurrence. The people at highest risk should be monitored more carefully and treated more intensively than others.Trial registration numberNTR5403.

Background. Diabetic foot ulcers (DFU) is among major health problems which impact the socio economic burden globally. We aimed at assessing the susceptibility pattern of antimicrobials in DFU infections among patients admitted in the Surgical Department at Kilimanjaro Christian Medical Centre (KCMC). Methods. This descriptive cross-sectional study was conducted from September 2018 through March 2019. Pus swabs were collected on the first day of admission by deep wound swabbing after irrigation with normal saline solution. Kirby-Bauer method was done according to the Clinical and Laboratory Standard Institute (CLSI) guidelines. Results. Sixty diabetic ulcer patients had 62 bacterial isolates. Majority of the isolates were gram negative 49/62(79.03%). The most common isolate was Escherichia coli 15/62(24.19%) followed by Pseudomonas aeruginosa 14/62(22.58%), Proteus mirabilis 8/62(12.9%) and Staphylococcus aureus 5/62(8.06%). Klebsiella pneumoniae, Coagulase Negative Staphylococcus, Proteus Vulgaris, and Streptococcus pyogenes each contributed 4/62(6.25%) isolates. Of the 49/62(79.3%) gram negative isolates, 8/49(16.33%) were mono resistant, 30/49(61.22%) were multiresistant, and 11/49(22.45%) were susceptible. Of the multi-resistant isolates, E. coli 12/15(80.00%), and P.aeruginosa 7/14(50.00%) were predominant. A total of 39/62(62.90%) isolates in patients contributed to poorer outcomes including loss of body part. Patients with ulcers infected by P. aeruginosa 11/39 (28.21%) had the highest number of surgical removal of body parts followed by E. coli 8/39(20.51%). Gram negative bacteria were highly susceptible to amikacin 91.18%, meropenem 93.33% and imipenem 95.24%. Isolates susceptibility to ceftriaxone was 32%. Conclusions. Amikacin, meropenem and imipenem can be safely used as broad-spectrum antimicrobials in DFU. The Standard of care remains culture and sensitivity of isolated microorganisms in combating diabetic foot ulcers infections.

Background Diabetic foot ulcers complications are the major cause of non-traumatic major limb amputation. We aimed at assessing the clinical profiles of diabetic foot ulcer patients undergoing major limb amputation in the Surgical Department at Kilimanjaro Christian Medical Centre (KCMC), a tertiary care hospital in North-eastern Tanzania. Methods A cross—sectional hospital-based study was conducted from September 2018 through March 2019. Demographic data were obtained from structured questionnaires. Diabetic foot ulcers were graded according to the Meggitt-Wagner classification system. Hemoglobin and random blood glucose levels data were retrieved from patients’ files. Results A total of 60 patients were recruited in the study. More than half (31/60; 51.67%) were amputated. Thirty-five (58.33%) were males. Fifty-nine (98.33%) had type II diabetes. Nearly two-thirds (34/60; 56.67%) had duration of diabetes for more than 5 years. The mean age was 60.06 ± 11.33 years (range 30–87). The mean haemoglobin level was 10.20 ± 2.73 g/dl and 9.84 ± 2.69 g/dl among amputees. Nearly two thirds (42/60; 70.00%) had a haemoglobin level below 12 g/dl, with more than a half (23/42; 54.76%) undergoing major limb amputation. Two thirds (23/31; 74.19%) of all patients who underwent major limb amputation had mean hemoglobin level below 12 g/dl. The mean Random Blood Glucose (MRBG) was 13.18 ± 6.17 mmol/L and 14.16 ± 6.10 mmol/L for amputees. Almost two thirds of the study population i.e., 42/60(70.00%) had poor glycemic control with random blood glucose level above 10.0 mmol/L. More than half 23/42 (54.76%) of the patients with poor glycemic control underwent some form of major limb amputation; which is nearly two thirds (23/31; 74.19%) of the total amputees. Twenty-eight (46.67%) had Meggitt-Wagner classification grade 3, of which nearly two thirds (17:60.71%) underwent major limb amputation. Conclusion In this study, the cohort of patients suffering from diabetic foot ulcers treated in a tertiary care center in north-eastern Tanzania, the likelihood of amputation significantly correlated with the initial grade of the Meggit-Wagner ulcer classification. High blood glucose levels and anaemia seem to be also important risk factors but correlation did not reveal statistical significance.

Monitoring of diabetic foot infections is largely based on clinical assessment, which is limited by moderate reliability. We conducted a prospective study to explore monitoring of thermal asymmetry (difference between mean plantar temperature of the affected and unaffected foot) for the assessment of severity of diabetic foot infections. In patients with moderate or severe diabetic foot infections (International Working Group on the Diabetic Foot infection-grades 3 or 4) we measured thermal asymmetry with an advanced infrared thermography setup during the first 4–5 days of in-hospital treatment, in addition to clinical assessments and tests of serum inflammatory markers (white blood cell counts and C-reactive protein levels). We assessed the change in thermal asymmetry from baseline to final assessment, and investigated its association with infection-grades and serum inflammatory markers. In seven included patients, thermal asymmetry decreased from median 1.8°C (range: −0.6 to 8.4) at baseline to 1.5°C (range: −0.1 to 5.1) at final assessment (P = 0.515). In three patients who improved to infection-grade 2, thermal asymmetry at baseline (median 1.6°C (range: −0.6 to 1.6)) and final assessment (1.5°C (range: 0.4 to 5.1)) remained similar (P = 0.302). In four patients who did not improve to infection-grade 2, thermal asymmetry decreased from median 4.3°C (range: 1.8 to 8.4) to 1.9°C (range: −0.1 to 4.4; P = 0.221). No correlations were found between thermal asymmetry and infection-grades (r = −0.347; P = 0.445), CRP-levels (r = 0.321; P = 0.482) or WBC (r = −0.250; P = 0.589) during the first 4–5 days of hospitalization. Based on these explorative findings we suggest that infrared thermography is of no value for monitoring diabetic foot infections during in-hospital treatment.

Non-removable offloading is the 'gold standard' treatment for neuropathic diabetic plantar forefoot ulcers. However, removable offloading is the common 'standard of care'. We compared three removable offloading devices for ulcer healing efficacy. In this multicentre, randomised controlled trial, 60 persons with neuropathic diabetic plantar forefoot ulcers were randomly assigned to wear a custom-made knee-high cast [BTCC (bivalved TCC)], custom-made ankle-high cast shoe or a prefabricated ankle-high forefoot-offloading shoe (FOS). Primary outcome was healing at 12 weeks. Dynamic plantar pressures, daily stride count and treatment adherence were assessed on a randomly selected subset (n = 35). According to intention-to-treat analysis, 58% of patients healed with BTCC [OR 0·77 (95% CI 0·41-1·45) versus FOS], 60% with cast shoe [OR 0·81 (95% CI 0·44-1·49) versus FOS] and 70% with FOS (P = 0·70). Mean ± SD peak pressure in kPa at the ulcer site was 81 ± 55 for BTCC, 176 ± 80 for cast shoe and 107 ± 52 for FOS (P = 0·005); stride count was 4150 ± 1626, 3514 ± 1380 and 4447 ± 3190, respectively (P = 0·71); percentage of 2-week intervals that patients wore the device

Diabetic foot ulcers, complicated by osteomyelitis, can be treated by surgical resection, dead space filling with gentamicin-loaded calcium sulphate-hydroxyapatite (CaS-HA) biocomposite, and closure of soft tissues and skin. To assess the feasibility of this treatment regimen, we conducted a multicenter retrospective cohort study of patients after failed conventional treatments. From 13 hospitals we included 64 patients with forefoot (n = 41 (64%)), midfoot (n = 14 (22%)), or hindfoot (n = 9 (14%)) ulcers complicated by osteomyelitis. Median follow-up was 43 (interquartile range, 20&ndash, 61) weeks. We observed wound healing in 54 patients (84%) and treatment success (wound healing without ulcer recurrence) in 42 patients (66%). Treatment failures (no wound healing or ulcer recurrence) led to minor amputations in four patients (6%) and major amputations in seven patients (11%). Factors associated with treatment failures in univariable Cox regression analysis were gentamicin-resistant osteomyelitis (hazard ratio (HR), 3.847, 95%-confidence interval (CI), 1.065&ndash, 13.899), hindfoot ulcers (HR, 3.624, 95%-CI, 1.187&ndash, 11.060) and surgical procedures with gentamicin-loaded CaS-HA biocomposite that involved minor amputations (HR, 3.965, 95%-CI, 1.608&ndash, 9.777). In this study of patients with diabetic foot ulcers, complicated by osteomyelitis, surgical treatment with gentamicin-loaded CaS-HA biocomposite was feasible and successful in 66% of patients. A prospective trial of this treatment regimen, based on a uniform treatment protocol, is required.

Background Mechanical stress is important in causing and healing plantar diabetic foot ulcers, but almost always studied as peak pressure only. Measuring cumulative plantar tissue stress combines plantar pressure and ambulatory activity, and better defines the load on ulcers. Our aim was to explore differences in cumulative plantar tissue stress between people with healing and non-healing plantar diabetic foot ulcers. Methods We analyzed a subgroup of 31 patients from a randomized clinical trial, treated with a removable offloading device for their plantar diabetic forefoot ulcer. We measured in-device dynamic plantar pressure and daily stride count to calculate cumulative plantar tissue stress at the ulcer location and associated this with ulcer healing and ulcer surface area reduction at four weeks (Student's t and chi-square test for significance, Cohen's d for effect size). Findings In 12 weeks, 68% (n = 21) of the ulcers healed and 32% (n = 10) did not. No statistically significant differences were found for cumulative plantar tissue stress, plantar pressure or ambulatory activity between people with healed and not-healed ulcers. Cumulative plantar tissue stress was 25% lower for people with healed ulcers (155 vs. 207 MPa·s/day; P = 0.71; Effect size: d = 0.29). Post-hoc analyses in the 27 patients who self-reported to be adherent to wearing the device showed that cumulative plantar tissue stress was 49% lower for those who reached ≥75% ulcer surface area reduction at four weeks (140 vs. 275 MPa·s/day; P = 0.09; d = 0.76); smaller differences and effect sizes were found for peak pressure (24%), peak pressure-time integral (30%) and ambulatory activity (26%); (P-value range: 0.14–0.97; Cohen's d range: 0.14–0.70). Interpretation Measuring cumulative plantar tissue stress may provide insight beyond that obtained from plantar pressure or ambulatory activity alone, with regard to diabetic foot ulcer healing using removable offloading devices. These explorative findings provide baseline data for further studies on this relevant topic.

Early identification of diabetic foot complications and their precursors is essential in preventing their devastating consequences, such as foot infection and amputation. Frequent, automatic risk assessment by an intelligent telemedicine system might be feasible and cost effective. Infrared thermography is a promising modality for such a system. The temperature differences between corresponding areas on contralateral feet are the clinically significant parameters. This asymmetric analysis is hindered by (1) foot segmentation errors, especially when the foot temperature and the ambient temperature are comparable, and by (2) different shapes and sizes between contralateral feet due to deformities or minor amputations. To circumvent the first problem, we used a color image and a thermal image acquired synchronously. Foot regions, detected in the color image, were rigidly registered to the thermal image. This resulted in 97.8% ± 1.1% sensitivity and 98.4% ± 0.5% specificity over 76 high-risk diabetic patients with manual annotation as a reference. Nonrigid landmark-based registration with B-splines solved the second problem. Corresponding points in the two feet could be found regardless of the shapes and sizes of the feet. With that, the temperature difference of the left and right feet could be obtained.

OBJECTIVE Infection commonly complicates diabetic foot ulcers and is associated with a poor outcome. In a cohort of individuals with an infected diabetic foot ulcer, we aimed to determine independent predictors of lower-extremity amputation and the predictive value for amputation of the International Working Group on the Diabetic Foot (IWGDF) classification system and to develop a risk score for predicting amputation. RESEARCH DESIGN AND METHODS We prospectively studied 575 patients with an infected diabetic foot ulcer presenting to 1 of 14 diabetic foot clinics in 10 European countries. RESULTS Among these patients, 159 (28%) underwent an amputation. Independent risk factors for amputation were as follows: periwound edema, foul smell, (non)purulent exudate, deep ulcer, positive probe-to-bone test, pretibial edema, fever, and elevated C-reactive protein. Increasing IWGDF severity of infection also independently predicted amputation. We developed a risk score for any amputation and for amputations excluding the lesser toes (including the variables sex, pain on palpation, periwound edema, ulcer size, ulcer depth, and peripheral arterial disease) that predicted amputation better than the IWGDF system (area under the ROC curves 0.80, 0.78, and 0.67, respectively). CONCLUSIONS For individuals with an infected diabetic foot ulcer, we identified independent predictors of amputation, validated the prognostic value of the IWGDF classification system, and developed a new risk score for amputation that can be readily used in daily clinical practice. Our risk score may have better prognostic accuracy than the IWGDF system, the only currently available system, but our findings need to be validated in other cohorts.

Background: Non-removable knee-high devices, such as a total contact cast (TCC), are recommended for offloading diabetic plantar forefoot ulcers. However, it is insufficiently known how each of the different design characteristics of these devices contribute to offloading the diabetic foot. Research question: What is the offloading effect of the different design characteristics that make up a non-removable knee-high cast for people with diabetes and active or previous plantar forefoot ulcers? Methods: Sixteen persons with diabetes, peripheral neuropathy and a healed or active plantar forefoot ulcer had their plantar pressures measured during walking in a non-removable knee-high device (TCC), in that device made removable (BTCC), in that device made below-ankle (cast shoe), in that cast shoe worn with a different walking sole and in a newly made cast shoe without a custom-moulded foot-device interface. Peak pressures, force-time integral, and perceived walking comfort were assessed. Results: Compared with the BTCC, peak pressures in the TCC were 47% (P = 0.028), 26% (P = 0.003) and 15% (P = 0.050) lower at the hallux, midfoot and (previous) ulcer location, respectively. Compared to the cast shoe, peak pressures in the BTCC were 39–43% and 47% (both P < 0.001) lower in the forefoot regions and (previous) ulcer location, respectively. The total force-time integral was 21% and 11% (P < 0.007) lower in the TCC and BTCC compared to the cast shoe. Perceived walking comfort was 5.6 in the TCC and 6.5 in the BTCC (P = 0.037). Effects of the other design characteristics (i.e. walking sole and plantar moulding) were non-significant. Significance: The TCC gives superior offloading, mostly because of being a knee-high and non-removable device, providing an optimal ‘shaft effect’. The TCC does, however, negatively affect walking comfort. These results aid decision-making in offloading diabetic plantar forefoot ulcers.

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.

Aims: Diabetic complications, and in particular diabetic foot ulcers (DFUs), are associated with low health-related quality of life (HRQoL). We evaluated whether the presence of diabetic complications also influenced the improvement of HRQoL during DFU treatment.Methods: 1088 patients presenting for DFU treatment at the centers participating in the Eurodiale study were followed prospectively up to one year. HRQoL was measured both at presentation and after healing or at end of follow up, using EQ-5D: a standardized instrument consisting of five domains and a summary index. The influence of diabetic comorbidity on the course of HRQoL was evaluated for each of the EQ-5D outcomes in multi-level linear regression analyses, adjusting for baseline characteristics.Results: HRQoL improved in all EQ-5D outcomes over the course of treatment for those DFUs that healed. The few significant differences in the development of HRQoL between patients with and without comorbidity showed a more beneficial development for patients with comorbidity in DFUs that did not heal or healed slowly.Conclusions: Comorbidity does not hamper improvement of HRQoL in DFU treatment. On the contrary, HRQoL improved sometimes more in patients with certain comorbidity with hard-to-heal ulcers. (C) 2017 Elsevier Inc. All rights reserved.

Four off-loading devices used for the treatment of diabetic forefoot ulcers were compared: a custom-molded insole shoe, a cast MABAL shoe, a prefabricated pneumatic walking brace, and a bivalved total contact cast (BTCC). It was anticipated that all devices would significantly reduce forefoot plantar pressure compared with a control shoe. Sixteen healthy volunteers participated. Plantar pressures were evaluated using the Pedar system, while walking speed was determined using an optoelectric timer. Peak pressure (PP) of ten plantar areas and pressure–time integral for the first metatarsal area were analyzed statistically using a repeated measures analysis of variance. Forefoot pressures were significantly reduced compared with the control shoe for all devices (p

Foot infections are common in the diabetic patient. Early recognition, proper assessment, and prompt intervention are vital. A combination of surgery and antibiotics is mandatory in virtually all foot infections. The aim of surgery is 2-fold: first, to control the infection, and second, to attempt to salvage the leg. The eventual goal is always to preserve a functional limb. Foot deformities resulting from surgery may cause reulceration and a high morbidity. The surgical treatment of the infection largely consists of draining of pus and removal of all necrotic and infected tissue. Frequently, revascularization of the foot is needed to save the limb; thus, there must be a close cooperation with the vascular surgical service. The surgeon must have a thorough knowledge of foot anatomy and must be familiar with the defects in wound healing that are caused by diabetes. The outcome of surgery mainly depends on the skill, care, and experience of the surgeon. The best results are achieved within a multidisciplinary setting.

INTRODUCTION: Total Contact Casting (TCC) is considered the gold standard in the treatment of neuropathic diabetic foot ulcers. To overcome some disadvantages of TCC we developed a removable fiberglass combicast shoe - the MABAL shoe. PATIENTS AND METHODS: The MABAL shoe was used to treat 23 plantar ulcers. RESULTS: Before treatment the mean surface area was 2.0 cm 2 (0.5–7.1 cm 2 ). Twenty-one of 23 ulcers healed, with a mean healing time of 34 days (7–75 days). CONCLUSION: The MABAL shoe provides healing of neuropathic diabetic foot ulcers comparable to existing methods of treatment, while offering some potential advantages. The main advantages are mobilization of the ankle, removability of the cast and a less time consuming form of treatment.

Skin temperature assessment is a promising modality for early detection of diabetic foot problems, but its diagnostic value has not been studied. Our aims were to investigate the diagnostic value of different cutoff skin temperature values for detecting diabetes-related foot complications such as ulceration, infection, and Charcot foot and to determine urgency of treatment in case of diagnosed infection or a red-hot swollen foot. Materials and Methods: The plantar foot surfaces of 54 patients with diabetes visiting the outpatient foot clinic were imaged with an infrared camera. Nine patients had complications requiring immediate treatment, 25 patients had complications requiring non-immediate treatment, and 20 patients had no complications requiring treatment. Average pixel temperature was calculated for six predefined spots and for the whole foot. We calculated the area under the receiver operating characteristic curve for different cutoff skin temperature values using clinical assessment as reference and defined the sensitivity and specificity for the most optimal cutoff temperature value. Mean temperature difference between feet was analyzed using the Kruskal-Wallis tests. Results: The most optimal cutoff skin temperature value for detection of diabetes-related foot complications was a 2.2 degrees C difference between contralateral spots (sensitivity, 76%; specificity, 40%). The most optimal cutoff skin temperature value for determining urgency of treatment was a 1.35 degrees C difference between the mean temperature of the left and right foot (sensitivity, 89%; specificity, 78%). Conclusions: Detection of diabetes-related foot complications based on local skin temperature assessment is hindered by low diagnostic values. Mean temperature difference between two feet may be an adequate marker for determining urgency of treatment.

Although thermal imaging can be a valuable technology in the prevention and management of diabetic foot disease, it is not yet widely used in clinical practice. Technological advancement in infrared imaging increases its application range. The aim was to explore the first steps in the applicability of high-resolution infrared thermal imaging for noninvasive automated detection of signs of diabetic foot disease. The plantar foot surfaces of 15 diabetes patients were imaged with an infrared camera (resolution, 1.2 mm/pixel): 5 patients had no visible signs of foot complications, 5 patients had local complications (e.g., abundant callus or neuropathic ulcer), and 5 patients had diffuse complications (e.g., Charcot foot, infected ulcer, or critical ischemia). Foot temperature was calculated as mean temperature across pixels for the whole foot and for specified regions of interest (ROIs). No differences in mean temperature >1.5 °C between the ipsilateral and the contralateral foot were found in patients without complications. In patients with local complications, mean temperatures of the ipsilateral and the contralateral foot were similar, but temperature at the ROI was >2 °C higher compared with the corresponding region in the contralateral foot and to the mean of the whole ipsilateral foot. In patients with diffuse complications, mean temperature differences of >3 °C between ipsilateral and contralateral foot were found. With an algorithm based on parameters that can be captured and analyzed with a high-resolution infrared camera and a computer, it is possible to detect signs of diabetic foot disease and to discriminate between no, local, or diffuse diabetic foot complications. As such, an intelligent telemedicine monitoring system for noninvasive automated detection of signs of diabetic foot disease is one step closer. Future studies are essential to confirm and extend these promising early findings

Background Flexor tenotomy is a minimally invasive surgical alternative for the treatment of neuropathic diabetic foot ulcers on the distal end of the toe. The influence of infection on healing and time to heal after flexor tenotomy is unknown. Flexor tenotomy can also be used as a prophylactic treatment. The effectiveness as a prophylactic treatment has not been described before. Methods A retrospective study was performed with the inclusion of all consecutive flexor tenotomies from one hospital between January 2005 and December 2011. Results From 38 ulcers, 35 healed (92%), with a mean time to heal of 22 ± 26 days. The longest duration for healing was found for infected ulcers that were penetrating to bone (35 days; p = .042). Cases of prophylactic flexor tenotomies (n=9) did not result in any ulcer or other complications during follow-up. Conclusions The results of this study suggest that flexor tenotomy may be beneficial for neuropathic diabetic foot ulcers on the distal end of the toe, with a high healing percentage and a short mean time to heal. Infected ulcers that penetrated to bone took a significantly longer time to heal. Prospective research, to confirm the results of this retrospective study, should be performed.

Early detection of (pre-)signs of ulceration on a diabetic foot is valuable for clinical practice. Hyperspectral imaging is a promising technique for detection and classification of such (pre-)signs. However, the number of the spectral bands should be limited to avoid overfitting, which is critical for pixel classification with hyperspectral image data. The goal was to design a detector/classifier based on spectral imaging (SI) with a small number of optical bandpass filters. The performance and stability of the design were also investigated. The selection of the bandpass filters boils down to a feature selection problem. A dataset was built, containing reflectance spectra of 227 skin spots from 64 patients, measured with a spectrometer. Each skin spot was annotated manually by clinicians as “healthy” or a specific (pre-)sign of ulceration. Statistical analysis on the data set showed the number of required filters is between 3 and 7, depending on additional constraints on the filter set. The stability analysis revealed that shot noise was the most critical factor affecting the classification performance. It indicated that this impact could be avoided in future SI systems with a camera sensor whose saturation level is higher than $10^6$, or by postimage processing.

This article describes the rationale and protocol of a large data collection study in patients with new diabetic foot ulcers by the Eurodiale study group, a consortium of centers of expertise in the field of diabetic foot disease within Europe. This study is a multicenter, observational, prospective data collection study. Its main aim is to determine the major factors determining clinical outcome and outcome in terms of health-related quality of life and health care consumption. Between September 1, 2003, and October 1, 2004, in 14 European centers, all consecutive patients with diabetes and a new foot ulcer were included in the study and followed until the end point or for a maximum of 1 year. End points were healing of the foot, major amputation, or death. Data were collected on patient, foot, and ulcer characteristics and on diagnostic and management procedures. Furthermore, data were collected on health care organization, quality of life, and resource use. A total of 1232 patients were included in the study. Sixty-three percent of the patients were referred by their general practitioner or were self-referrals. Twenty-seven percent of the patients were admitted at the time of inclusion; 1088 patients were followed until the end point. “Optimal Organization of Health Care in Diabetic Foot Disease” is one of the first large multicenter studies in the field of diabetic foot disease on clinical presentation, clinical outcome, quality of life, resource utilization, and health care organization and their interrelationships. These data will provide us with new insights that enable us to improve care for these patients and guide the development of new studies in this area. The results of this study are the subject of a separate presentation.

Foot ulceration is the most costly complication of diabetes. The gold standard for healing foot ulcers on the plantar side of the foot is offloading by means of a non-removable total contact cast (TCC). Because of known complications with a TCC, removable alternatives have been developed.

Inflammation is an early and predictive warning sign for diabetic foot complications, and temperature has been proven to be a vicarious marker for inflammation. Studies have shown that infrared dermal thermography can be a valuable diagnostic tool for early recognition of diabetic foot ulceration, which in turn may prevent further complications.