METHODS: In this prospective, randomised, proof-of-concept study, patients with diabetes, and with peripheral neuropathy and a recent history of plantar foot ulceration were recruited from two multidisciplinary outpatient diabetic foot clinics in the UK, and were randomly assigned to either intervention or control. All patients received an insole system, which measured plantar pressure continuously during daily life. The intervention group received audiovisual alerts via a smartwatch linked to the insole system and offloading instructions when aberrant pressures were detected; the control group did not receive any alerts. The primary outcome was plantar foot ulcer occurrence within 18 months. This trial is registered with ISRCTN, ISRCTN05585501, and is closed to accrual and complete.
FINDINGS: Between March 18, 2014, and Dec 20, 2016, 90 patients were recruited and consented to the study, and 58 completed the study. At follow-up, ten ulcers from 8638 person-days were recorded in the control group and four ulcers from 11 835 person-days in the intervention group: a 71% reduction in ulcer incidence in the intervention group compared with the control group (incidence rate ratio 0·29, 95% CI, 0·09-0·93; p=0·037). The number of patients who ulcerated was similar between groups (six of 26 [control group] vs four of 32 [intervention group]; p=0·29); however, individual plantar sites ulcerated more often in the control group (ten of 416) than in the intervention group (four of 512; p=0·047). In an exploratory analysis of good compliers (n=40), ulcer incidence was reduced by 86% in the intervention group versus control group (incidence rate ratio 0·14, 95% CI 0·03-0·63; p=0·011). In the exploratory analysis, plantar callus severity (change from baseline to 6 months) was greater in re-ulcerating patients (6·5, IQR 4·0-8·3) than non-re-ulcerating patients (2·0, 0·0-4·8; p=0·040).
INTERPRETATION: To our knowledge, this study is the first to show that continuous plantar pressure monitoring and dynamic offloading guidance, provided by an innovative intelligent insole system, can lead to a reduction in diabetic foot ulcer site recurrence.
FUNDING: Diabetes UK and Orpyx Medical Technologies.
METHODS: This article was divided into the following parts: Part 1 Surface roughness and substance loss: an in vitro study, which involves intact extracted teeth sectioned and treated using a piezoelectric ultrasonic device (PM200 EMS Piezon, Switzerland) with a conventional scaler tip (FS-407) and a Perio Slim (PS) scaler tip (Perio Slim DS-016A). All sectioned samples for tooth surface roughness (n = 20) and tooth substance loss (n = 46) analyses were measured and compared using a 3D surface texture analyser and scanning electron microscope (SEM) respectively, at baseline and following scaling. Part 2 Pain Perception: a clinical study, which was a split mouth study design including 30 participants with gingivitis and/or mild chronic periodontitis; treated with supra-gingival scaling from teeth #13 to #23. Subjects were randomised to group A or group B. Group A was treated first with PS scaler tips, whereas group B was treated first with conventional scaler tips. Pain perception was recorded using the visual analogue scale (VAS).
RESULTS: In vitro study: both scaler tips caused significant reduction in root substance roughness after scaling (p 0.05) was observed. The PS scaler tip caused statistically significantly less root substance loss (p design causes less tooth substance loss compared to a wider scaler tip design. In the clinical study, less pain was observed compared than a wide (conventional) scaler tip design.
OBJECTIVE: This study was carried out to identify important parameters in designing tasks that efficiently assess hand function of stroke patients and to quantify potential benefits of robotic assessment modules to predict the conventional assessment score with iRest.
METHODS: Twelve predictive variables were explored, relating to movement time, velocity, strategy, accuracy and smoothness from three robotic assessment modules which are Draw I, Draw Diamond and Draw Circle. Regression models using up to four predictors were developed to describe the MAS.
RESULTS: Results show that the time given should be not too long and it would affect the trajectory error. Besides, result also shows that it is possible to use iRest in predicting MAS score.
CONCLUSION: There is a potential of using iRest, a non-motorized device in predicting MAS score.
METHODOLOGY: This is a descriptive cross-sectional study at the Sleep Clinic, Department of Otorhinolaryngology-Head and Neck Surgery. Flexible nasopharyngolaryngoscopy was performed in seated erect and supine position. Retropalatal and retroglossal regions were continuously recorded during quiet breathing and Mueller's maneuver in both positions. Captured images were measured using Scion Image software and narrowing rate was calculated. Level of each site was classified based on Fujita classification and severity of obstruction using Sher scoring system for Mueller's maneuver.
RESULTS: A total of 59 patients participated in this study. Twenty-nine (49.2%) participants had type 1 (retropalatal) obstruction, 23 (38.9%) had type 2 (retropalatal and retroglossal), and seven (11.9%) in type 3 (retroglossal) obstruction. Fifty (84.7%) of the patients have severe obstruction at the retropalatal region in supine position (SRP) followed by 35 (59.3%) at retropalatal region in erect position (ERP), 27 (45.8%) at retroglossal region in supine position (SRG) and eight (13.5%) at retroglossal region in erect position (ERG). The average oxygen saturation showed significant association in ERP (P = 0.012) and SRP (P < 0.001), but not significant in ERG and SRG.
CONCLUSIONS: Videoendoscopy utilizing flexible nasopharyngolaryngoscopy and Scion Image software is reliable, minimally invasive, and useful as an office procedure in evaluating the multilevel obstruction of upper airway in OSA patients. The retropalatal region has more severe obstruction compared with retroglossal region either in erect or supine position.
OBJECTIVE: The purpose of this study was to report the worldwide experience with successful retrieval of the Micra TPS.
METHODS: A list of all successful retrievals of the currently available leadless pacemakers (LPs) was obtained from the manufacturer of Micra TPS. Pertinent details of retrieval, such as indication, days postimplantation, equipment used, complications, and postretrieval management, were obtained from the database collected by the manufacturer. Other procedural details were obtained directly from the operators at each participating site.
RESULTS: Data from the manufacturer consisted of 40 successful retrievals of the Micra TPS. Operators for 29 retrievals (73%) provided the consent and procedural details. Of the 29 retrievals, 11 patients underwent retrieval during the initial procedure (immediate retrieval); the other 18 patients underwent retrieval during a separate procedure (delayed retrieval). Median duration before delayed retrieval was 46 days (range 1-95 days). The most common reason for immediate retrieval was elevated pacing threshold after tether removal. The most common reasons for delayed retrieval included elevated pacing threshold at follow-up, endovascular infection, and need for transvenous device. Mean procedure duration was 63.11 ± 56 minutes. All retrievals involved snaring via a Micra TPS delivery catheter or steerable sheath. No serious complications occurred during the reported retrievals.
CONCLUSION: Early retrieval of the Micra TPS is feasible and safe.