OBJECTIVEThe role of telemedical monitoring in diabetic foot ulcer care is still uncertain. Our aim was to compare telemedical and standard outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. RESEARCH DESIGN AND METHODSOf the 736 screened individuals with diabetic foot ulcers, 401 met the eligibility criteria and were randomized between October 2010 and November 2014. The per-protocol telemedical monitoring consisted of two consultations in the patient's own home and one consultation at the outpatient clinic. Standard practice consisted of three outpatient clinic visits. The three-visit cycle was repeated until study end point. The study end points were defined as complete ulcer healing, amputation, or death. RESULTSOne hundred ninety-three individuals were randomized to telemedical monitoring and 181 to standard care. Demographics were similar in both groups. A causespecific Cox proportional hazards model showed no difference in individuals monitored through telemedicine regarding wound healing (hazard ratio 1.11 [95% CI 0.87, 1.42], P = 0.42) or amputation (0.87 [0.54, 1.42], P = 0.59). We found a higher mortality incidence in the telemedical monitoring group compared with the standard outpatient monitoring group (8.68 [6.93, 10.88], P = 0.0001). CONCLUSIONSThe findings of no significant difference regarding amputation and healing between telemedical and standard outpatient monitoring seem promising; however, for telemedical monitoring, a higher mortality throws into question the role of telemedicine in monitoring diabetic foot ulcers. Further studies are needed to investigate effects of telemedicine on mortality and other clinical outcomes and to identify patient subgroups that may have a poorer outcome through telemedical monitoring.Diabetes currently affects .387 million people worldwide, and this number is expected to rise to .592 million individuals worldwide by 2035 (1). In Denmark, 320,545 people suffer from diabetes, and it is estimated that a further 200,000 individuals are undiagnosed; a further 750,000 have impaired glucose tolerance (2). Approximately 7-15% of the population with diabetes will have one or several foot ulcers during a lifetime, and up to 70% of these ulcers will recur during a 5-year period (3). Diabetic foot ulcers lead to ;500 major amputations every year in
This randomised study indicates a potential beneficial effect of ESWT on ulcer healing as well as tissue oxygenation. Owing to weaknesses of the study and the fact that ulcer healing was not significantly improved in the intervention group compared with the control group, a larger randomised trial with blinded design is suggested.
IntroductionIntensive care unit (ICU) patients are predisposed to thromboembolism. Routine prophylactic anticoagulation is widely recommended. Low-molecular-weight heparins, such as enoxaparin, are increasingly used because of predictable pharmacokinetics. This study aims to determine the subcutaneous (SC) dose of enoxaparin that would give the best anti-factor Xa levels in ICU patients.MethodsThe 72 patients admitted to a mixed ICU at Odense University Hospital (OUH) in Denmark were randomised into four groups to receive 40, 50, 60, or 70 mg SC enoxaparin for a period of 24 hours. Anti-factor Xa activity (aFXa) was measured before, and at 4, 12, and 24 hours after administration. An AFXa level between 0.1 to 0.3 IU/ml was considered evidence of effective antithrombotic activity.ResultsMedian peak (4 hours after administration), aFXa levels increased significantly with an increase in enoxaparin dose, from 0.13 IU/ml at 40 mg, to 0.14 IU/ml at 50 mg, 0.27 IU/ml at 60 mg, and 0.29 IU/ml at 70 mg (P = 0.002). At 12 hours after administration, median aFXa levels were still within therapeutic range for those patients who received 60 mg (P = 0.02).ConclusionsOur study confirmed that a standard dose of 40 mg enoxaparin yielded subtherapeutic levels of aFXa in critically ill patients. Higher doses resulted in better peak aFXa levels, with a ceiling effect observed at 60 mg. The present study seems to suggest inadequate dosage as one of the possible mechanisms for the higher failure rate of enoxaparin in ICU patients.Trial RegistrationISRCTN03037804
This study compared the cost-effectiveness of telemonitoring with standard monitoring for patients with diabetic foot ulcers. The economic evaluation was nested within a pragmatic randomised controlled trial. A total of 374 patients were randomised to either telemonitoring or standard monitoring. Telemonitoring consisted of two tele-consultations in the patient's own home and one consultation at the outpatient clinic; standard monitoring consisted of three outpatient clinic consultations. Total healthcare costs were estimated over a 6-month period at individual patient level, from a healthcare sector perspective. The bootstrap method was used to calculate the incremental cost-effectiveness ratio, and one-way sensitivity analyses were performed. Telemonitoring costs were found to be €2039 less per patient compared to standard monitoring; however, this difference was not statistically significant. Amputation rate was similar in the two groups. In conclusion, a telemonitoring service in this form had similar costs and effects as standard monitoring.
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