Design and evaluation of an implementation strategy of a diabetic foot program in primary care: study protocol for a cluster randomized controlled trial (iMplanta study)

BACKGROUND: Diabetic foot is one of the most severe complications of diabetes mellitus, with physical, psychological, social, and economic consequences. Evidence suggests that up to 75-80% of diabetic foot complications are preventable through appropriate preventive care. Although structured preventive protocols, such as the Diabetic Foot Program, have been adapted for the primary care in Spain, their integration into routine clinical practice remains suboptimal. This paper describes the protocol for the iMplanta study, which aims to evaluate the effectiveness of an implementation strategy for the Diabetic Foot Program in primary care. METHODS: The iMplanta study is a two-arm cluster randomized controlled trial to be conducted in 20 primary care centres (PCCs) in Mallorca (Balearic Islands, Spain). PCCs will be randomly allocated (1:1) to either an intervention group or a control group. The intervention group will receive a structured implementation strategy for the Diabetic Foot Program developed using the Implementation Mapping framework, while the control group will continue with usual care, applying the Diabetic Foot Program without additional implementation support. Data will be collected at three time points: baseline (covering the 12 months prior to study initiation) and 6 and 12 months post-implementation. Implementation outcomes will be evaluated using the RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance), complemented by Proctor et al. implementation outcomes (acceptability, feasibility, and appropriateness). DISCUSSION: This study will generate evidence on how to effectively implement a preventive Diabetic Foot Program in real-world primary care. By applying implementation science principles, iMplanta aims to inform sustainable and transferable implementation strategies to increase uptake of evidence-based diabetic foot prevention and improve care delivery for people living with diabetes. TRIAL REGISTRATION: Prospectively registered on ClinicalTrials.gov, no. NCT07004179. Date of registration February 20, 2025.