Investigating and implementing scalable interventions to prevent diabetic foot ulcers

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Lower limb amputation is a devastating and preventable complication of type 2 diabetes. As the burden of diabetes rises, particularly in low- and middle-income countries (LMICs), diabetes care remains limited in many settings, including the management of complications. Diabetic foot ulcers (DFU) can be prevented with screening, particularly in high-risk individuals, by actively engaging them in foot monitoring behaviours.The proposed research project will take place at the Universidad Peruana Cayetano Heredia (Peru) in collaboration with several institutions and will develop and test an innovative approach for the prevention of diabetic foot ulcers (DFU). The project has three work packages (WP). In WP1, the study will 1) develop an artificial intelligence (AI) algorithm that will identify signs prior to ulcer onset using foot selfie images, 2) co-design a foot selfie mHealth tool for the prevention of DFU, and 3) pilot-test the foot selfie mHealth tool to assess usability and accuracy of the AI algorithm. In WP2, the study will assess whether foot selfie and foot thermometry are more effective than enhanced usual care in preventing DFU and whether the foot selfie is non-inferior to foot thermometry. WP3 is focused on engagement with stakeholders and implementation and runs across the entire duration of the project to explore how these interventions can be implemented in the Peruvian health system. WP3 includes a detailed process evaluation to understand for whom the complex interventions (foot selfie and foot thermometry) worked for, as well as how and why, throughout this project. In addition, the economic evaluation will assess the cost-effectiveness of the interventions. The project is also committed to building individual and institutional capacity. First, enhancing community research engagement, bringing representatives from patient organisations to sit on the board and attend regular project meetings. Second, actively engaging in building the capacity of our wider network of research partners, such as patients and their families, advocacy organisations, and policymakers to enhance the incorporation of 'lived' evidence into research and increase the potential for uptake into policy. Our proposal encompasses several pragmatic innovations, much needed in LMIC settings. This home-based, easy-to-use, low-cost mHealth foot selfie tool promotes the habit of foot self-monitoring and can contribute to the primary prevention of DFU through tailored guidance and early triage of features of concern. The photographic documentation of the feet captured over time can provide objective assessments that can be used prospectively by healthcare providers. Telemedicine addresses the limitations in the provision of in-person chronic care, which have been exacerbated during the COVID-19 pandemic. The use of images at the pre-ulcer stage to develop a strategy for the prevention of DFU is novel and the use of AI in the prevention of DFU has not been previously studied. Finally, testing two interventions in an LMIC setting with a three-arm non-inferiority design is a robust methodological approach that uses a versatile trial platform.The findings from this project are oriented to overcome the limitations in providing chronic care in LMICs and the shortage of diabetes and DFU specialists. The social impact of the project relies on the interruption or avoidance of the path towards foot ulcers and amputation, thus improving the quality of life of people living with diabetes.