Computational protocol: Long-term effects on the progress of neuropathy after diabetic Charcot foot: an 8.5-year prospective case–control study

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Protocol publication

[…] A total of 49 patients were included at the baseline visit in 2005–2007 [, ]. All 49 patients were followed up using medical records, the “Danish Register of Cause of Death” and the “Danish Civil Registration System”. The included patients were 61.7 ± 7.2 years old and were distributed as 40 males and 9 females. Ten patients had type 1 diabetes, and 39 had type 2 diabetes.At baseline in 2005–2007 all examination were performed by author TMC, and at follow-up by author RBJ. All examinations were performed using the same equipment and the same procedures. Patients were examined in order of their availability over an 11 months period at the Endocrine Research Unit at Bispebjerg Hospital, Denmark.Physical examinations focused on the lower extremities including deformities, wounds and loss-of-function. The degree of neuropathy was assessed by the modified questionnaire Neuropathy Symptom Score (NSS) (Additional file : Appendix S1) [, ]. In addition, vibration perception thresholds was measured by biothesiometry (Biothesiometer, Bio-Medical Instruments Co, Newbury, Ohio 44065, USA), with the probe placed on the hallux pulpa [–].Cardial Autonomic Neuropathy (CAN) was assessed using the heart rate variability method by utilizing the autonomic cardiac regulation. Measurements were done using PowerLab, Chart 5 v5.5 (ADInstruments Pty Ltd, Castle Hill, NSW, Australia). For electrocardiography measurement three electrodes were placed on the patient’s chest. The patient was instructed to rest for 10 min, after which baseline readings were taken. The patient was then instructed to adjust their respiration rate to 6 steady breaths per minute for 1 min, each inspiration and expiration phase taking 5 s. This was controlled with a stopwatch and under constant instruction and monitoring. The procedure was repeated five times with 5 min of rest between measurements. The measurements selected as results were the ones which were evaluated to display the best compliance to the instructions (based on respiration and heart-rate pattern) [].Blood flow in the feet was measured using venous occlusion plethysmography [, ] with a Hokanson EC6 Plethysmograph with a Hokanson E20 Rapid Cuff Inflator (Bellevue, WA, USA). The measurements were done with the patient lying on his/her back after a rest period of 30 min. The cuff was placed around the calf, and a fitting strain gauge was placed around the forefoot. Cuff pressure was 40 mmHg for 7 s, and the inflation was repeated 5 times on each foot.Data are expressed as means ± 1 Standard Deviation (SD) unless otherwise noted. Normal distribution was controlled with the Shapiro-Wilks tests. T-tests and Mann–Whitney rank sum tests were used for comparisons between two data sets (parametric and non-parametric respectively).For variance analysis between multiple ranked groups the non-parametric Kruskal–Wallis one way analysis of variance was used. For matched groups (e.g. baseline versus follow-up) paired t-tests and Wilcoxon signed rank tests were used. For compairing categorical data (2 × 2 tables), Chi square test was used. Results were adjusted using Bonferroni correction when applicable (multiple comparisons).Statistics and generel data handling was done using IBM SPSS Statistics v. 23 by IBM Corporation, SIGMAPLOT v. by Systat Software Inc., Microsoft Excel 2000 v. 9.0.2812 by Microsoft Corporation and Apache OpenOffice 4.0.1 by The Apache Software Foundation. […]

Pipeline specifications

Software tools SPSS, SigmaPlot
Application Miscellaneous
Organisms Homo sapiens
Diseases Arterial Occlusive Diseases, Autonomic Nervous System Diseases, Diabetes Mellitus, Diabetic Neuropathies, Nervous System Diseases