JMIR Publications

ABSTRACT

Background:

Diabetes-related foot disease is a major cause of preventable morbidity, lower-limb amputations, and healthcare expenditures worldwide. Early identification of risk factors, patient education, and continuous monitoring are essential to preventing complications; however, access to specialized diabetic foot care remains limited, particularly in primary healthcare settings. Although digital health technologies and artificial intelligence have shown promise in supporting diabetic foot assessment and management, many existing solutions focus primarily on lesion detection and clinical diagnosis, with limited emphasis on prevention, self-care support, health education, and longitudinal monitoring. There remains a need for evidence-based digital tools capable of integrating preventive care, patient engagement, and remote monitoring to support diabetic foot management across different levels of care.

Objective:

This study aimed to design, develop, and validate the content of i9 Pé, a digital health platform intended to support diabetic foot prevention, risk assessment, health education, and remote monitoring in primary care settings. Additionally, the study sought to evaluate the platform’s content validity, usability, and applicability through expert assessment, providing evidence to support its future implementation and integration with artificial intelligence–based functionalities for diabetic foot management.

Methods:

A methodological study was conducted between 2024 and 2026 to design, develop, and validate the content of the i9 Pé platform. The study was developed in three sequential phases. First, a scoping review was conducted following the Joanna Briggs Institute framework and PRISMA-ScR recommendations to identify evidence regarding digital health technologies and artificial intelligence applications for diabetic foot prevention and management. The findings informed the platform’s clinical, educational, and technological requirements. Second, the i9 Pé platform was developed using a user-centered design approach. The platform was designed to support diabetic foot prevention through risk assessment, health education, self-care promotion, remote monitoring, and future integration of artificial intelligence–based functionalities. The technological architecture included patient and healthcare professional modules, educational resources, gamification strategies, image capture capabilities, and monitoring tools. Third, content validation was performed by a panel of 11 specialists with expertise in podiatry, diabetic foot care, wound management, teaching, research, or healthcare management. Participants evaluated the platform using a structured instrument comprising five domains: Objectives, Organization, Writing and Language, Appearance and Design, and Motivation and Usability. Responses were recorded on a 5-point Likert scale. Quantitative data were analyzed using descriptive statistics, the Content Validity Index (CVI), and Cronbach’s alpha coefficient. Qualitative comments were analyzed using thematic content analysis and visual mapping with ATLAS.ti software. The study was approved by the Research Ethics Committee under CAAE number 94573925.0.0000.5537.

Results:

The i9 Pé platform was successfully developed as a digital health solution designed to support diabetic foot prevention, risk assessment, health education, remote monitoring, and future artificial intelligence integration in primary care settings. The platform architecture included patient-centered educational resources, gamified self-care pathways, image capture functionalities, risk assessment tools, and a professional monitoring dashboard. A total of 11 specialists participated in the content validation process. Overall evaluation demonstrated a high level of agreement regarding the platform’s relevance, applicability, and usability. The global mean score across all evaluated domains was 4.27 out of 5. The Objectives domain achieved the highest score (mean 4.72), followed by Motivation and Usability (mean 4.29), indicating strong agreement regarding the platform’s potential to support diabetic foot prevention and monitoring. The Organization, Writing and Language, and Appearance and Design domains also achieved satisfactory evaluations, with mean scores ranging from 4.17 to 4.20. The overall Scale-Level Content Validity Index (S-CVI) was 0.91, demonstrating excellent content validity. Internal consistency analysis revealed excellent reliability, with an overall Cronbach alpha coefficient of 0.93. Qualitative analysis identified recommendations related to expansion of preventive educational content, simplification of technical terminology, enhancement of health literacy strategies, and inclusion of additional guidance on neuropathy, peripheral arterial disease, fungal infections, and early diabetic foot risk identification. Overall, specialists recognized the platform as a clinically relevant and potentially useful digital health technology for diabetic foot prevention and management.

Conclusions:

The i9 Pé platform demonstrated satisfactory content validity and excellent reliability, supporting its potential use as a digital health tool for diabetic foot prevention and monitoring in primary care. The integration of risk assessment, health education, self-care support, remote monitoring, and future artificial intelligence capabilities provides a comprehensive approach to addressing gaps in diabetic foot prevention and management. Expert feedback confirmed the platform’s clinical relevance, usability, and applicability while identifying opportunities for further refinement. These findings support the continued development and future evaluation of the platform in real-world healthcare settings to assess user engagement, implementation outcomes, and its contribution to reducing diabetes-related foot complications and preventable amputations. Clinical Trial: Not applicable. This methodological study involved the design, development, and content validation of a digital health platform and did not constitute a clinical trial.