Study protocol for a randomized controlled trial to test for preventive effects of diabetic foot ulceration by telemedicine that includes sensor-equipped insoles combined with photo documentation
Abstract
BackgroundEarly detection of diabetic foot ulcerations (DFUs) can avoid or delay any progression into more severe stages, which may require limb amputation or lead to infectious sequelae and death. However, frequent clinical screening would be too intrusive and costly, and self-examination may be hampered by concomitant diseases and social disabilities. In addition, it requires professional knowledge and experience using specialized devices. Researchers reported that skin temperature monitoring could reduce the risk of DFUs in high-risk patients. The main research objects in this field are effective and convenient means of temperature measurement, accurate and reasonable early warning mechanisms, and timely and appropriate interventions. This trial aims to investigate the effectiveness of daily home-based foot temperature measurements in the prevention of DFUs with the aid of intelligent sensor-equipped insoles combined with photo documentation.Methods/DesignIn this open-label, prospective, randomized, 24-month trial, 300 patients with diabetes mellitus (type 1 or 2) and severe diabetic peripheral neuropathy (vibration sensation ≤ 4/8), aged 18–85 years, will be recruited and assigned to control and intervention groups in a ratio of 1:1. Main inclusion criteria to be eligible for study participation encompass in particular risk group 2 or 3 for the development of DFUs using the diabetic foot risk classification system (as specified by the International Working Group on the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 300 participants or records.
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