Abstract
Introduction: The skin of people with diabetic foot disease is thought to heat up from ambulatory activity before it breaks down into ulceration. We assessed cost-effectiveness and cost-utility of at-home foot skin temperature monitoring for ulcer prevention in people with diabetes. Methods: In this outcome-assessor-blinded multicenter RCT, we randomly assigned people with diabetes, neuropathy, foot ulcer history or Charcot’s neuro-arthropathy to usual care (i.e., podiatric treatment, education, and therapeutic footwear) or usual care plus measuring skin temperatures at 6-8 plantar sites per foot each day (enhanced therapy). Foot care costs from a societal perspective were obtained via institute for Medical Technology Assessment questionnaires and from health records. Utilities were calculated based on health-related quality of life as assessed with the EQ-5D-3L. Primary clinical outcome for effectiveness was foot ulcer recurrence. Group differences were assessed by calculating 95% confidence intervals after correction for bias and using accelerated non-parametric bootstrapping. Results: Total foot care costs per participant during 18-months follow-up were significantly lower in the intervention group (n=151; €4007 (SD: €6349)) compared to usual care (n=153; €6872 (SD: 15251); p=0.033). The intervention had 99.3% probability of being cost-effective at a willingness-to-pay of €50,000. Quality-adjusted life years were lower in the intervention group (1.09 (SD: 0.35)) than in usual care (1.12 (SD: 0.34); p=0.397). The intervention had 69.0% probability of achieving cost-utility at a willingness-to-pay of €50,000. Conclusion: In this first-ever societal-perspective cost-effectiveness RCT in the field of diabetic foot disease, we found at-home foot skin temperature monitoring a cost-effective intervention in foot ulcer prevention, at the expense of lower quality of life. Disclosure J. Van netten: None. W. B. Aan de stegge: None. M. Dijkgraaf: None. S. A. Bus: None. Funding Netherlands Organization for Health Research and Development (837002508); Dutch Society for Podiatrists; Dutch Branch Organization for Pedicures
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