Modelling the cost-effectiveness of electric stimulation therapy in non-healing venous leg ulcers.
ABSTRACT To estimate the cost-effectiveness of using electric stimulation (ES) therapy (Accel-Heal) plus dressings and compression bandaging compared with dressings and compression bandaging alone in treating chronic, non-healing venous leg ulcers (VLUs) of >6 months' duration from the perspective of the National Health Service (NHS) in the UK.
A 5-month Markov model was constructed, depicting the management of a chronic, non-healing VLU of >6 months' duration. The model considers the decision by a clinician to continue with a patient's previous care plan (comprising dressings and compression bandaging) or treating with ES therapy plus dressings and compression bandaging. The model was used to estimate the relative cost-effectiveness of ES therapy at 2008-2009 prices.
According to the model, 38% of VLUs are expected to heal within 5 months after starting ES therapy, with a further 57% expected to improve. This improvement in clinical outcome is expected to lead to a 6% health gain of 0.017 QALYs (from 0.299 to 0.316 QALYs) over 5 months. The model also showed that using ES therapy instead of continuing with a patient's previous care plan is expected to reduce the NHS cost of managing them by 15%, from £880 to £749, due in part to a 27% reduction in the requirement for nurse visits (from mean 49.0 to 35.9 visits per patient) over the first 5 months after the start of treatment. Hence, use of ES therapy was found to be a dominant treatment (improved outcome for less cost).
Within the model's limitations, use of ES therapy potentially affords the NHS a cost-effective treatment, compared with patients remaining on their previous care plan in managing chronic, non-healing VLUs of >6 months' duration. However, this is dependant on the number of ES therapy units per treatment, the unit cost of the device, and the number of nurse visits required to manage patients in clinical practice.
This study was sponsored by Synapse Microcurrent Ltd., manufacturers of Accel-Heal. The authors have no other conflicts of interest that are directly relevant to the content of this manuscript. In particular, Synapse Microcurrent Ltd. had no role in the study design, in the collection, analysis and interpretation of data, or in writing the manuscript.
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ABSTRACT: We conducted a systematic review to investigate the effect of electrical stimulation on ulcer healing compared to usual treatment and/or sham stimulation. This systematic review also aimed to investigate the effect of different types of electrical stimulation on ulcer size reduction. MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials (CENTRAL) were searched from inception to October 2013 on randomised controlled trials (RCTs), in English and on human subjects, which assessed the effect of electrical stimulation on ulcer size as compared to standard care and/or sham stimulation. Data from included RCTs were pooled with use of fixed and random effects meta-analysis of the weighted mean change differences between the comparator groups. Heterogeneity across studies was assessed with the I² statistic. 21 studies were eligible for inclusion in the meta-analysis. In 6 trials (n=210), electrical stimulation improved mean percentage change in ulcer size over total studies periods by 24.62%, 95% Confidence Interval (CI) 19.98 to 29.27, p<0.00001 with no heterogeneity. In 3 trials (n=176), electrical stimulation insignificantly improved mean weekly change in ulcer size by 1.64%, 95% (CI) -3.81 to 7.09, p=0.56 with significant heterogeneity (I(2) =96%, p<0.00001). In 6 trials (n=266), electrical stimulation decreased ulcer size by 2.42 cm(2) , 95% (CI) 1.66 to 3.17, p<0.00001, with significant heterogeneity. In one trial (n=16), electrical stimulation also insignificantly improved the mean daily percentage change in ulcer size by 0.63%, 95% (CI) -0.12 to 1.37, p=0.10, with significant heterogeneity. Electrical stimulation appears to increase the rate of ulcer healing and may be superior to standard care for ulcer treatment. This article is protected by copyright. All rights reserved.European Journal of Clinical Investigation 01/2014; 44(4). DOI:10.1111/eci.12244 · 2.83 Impact Factor
International angiology: a journal of the International Union of Angiology 04/2014; 33(2):87-208. · 1.01 Impact Factor
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ABSTRACT: This study investigated the effect of low-intensity cathodal direct current on the release of plasma vascular endothelial growth factor (VEGF) and nitric oxide (NO) in diabetic foot ulceration. Twenty type 2 diabetic patients with foot ulceration and thirteen age-matched healthy subjects were enrolled. Patients were randomly assigned to electrical stimulation (ES) (n = 10) or sham ES (placebo, n = 10) groups. The ES group received cathodal direct current (1.48 +/– 0.98 mA) for 1 h/d,3 d/wk for 4 wk (12 sessions). Blood samples were collected for VEGF and NO measurement in the first and last treatment sessions before and after intervention. Wound surface area and skin temperature were measured at the 1st, 6th, and 12th sessions. VEGF significantly increased in the ES group compared with the placebo group after the 1st (106.61 +/– 79.50 and 40.88 +/– 26.20, respectively) and 12th sessions (109.28 +/– 67.30 and 34.79 +/– 13.20, respectively). NO level also increased significantly in the ES group compared with the placebo group after the 12th session (44.21 +/– 14.00 and 35.25 +/–11.00, respectively). The increase of skin temperature was significantly higher in the ES group than the placebo group. Application of low-intensity ES increases the expression of VEGF and NO, which may lead to improved blood flow and tissue temperature and, consequently, wound healing in diabetic foot ulceration.The Journal of Rehabilitation Research and Development 01/2014; 51(5):815-24. · 1.69 Impact Factor