Implementation of a Diabetic Foot Prevention Strategy in Primary Care (iMplanta Study)

The goal of this two-arm cluster randomised controlled trial (RCT) is to evaluate the effectiveness of a new implementation strategy based on the ImM model for the Protocol of assistance to the person with diabetic foot (PAPDF) of the Balearic Islands Health Service in reducing complications of diabetic foot, compared to the current implementation strategy, in the primary care centers of Majorca. As secondary objectives we aim 1. To determine the reach of the implementation strategy in the GAPM primary care centers, 2.To compare the effectiveness of the PAPDF versus usual care in preventing diabetic foot complications, 3. To identify the number of healthcare professionals adhering to the implementation strategy and 4. To assess the sustainability of the implementation strategy over time.

NCT Number	NCT07004179
Lead Sponsor	University of the Balearic Islands Collaborators: Universitat de les Illes Balears
Conditions	Diabetic Foot Disease, Diabetic Foot Ulcer (DFU)
Enrollment	1,520 participants
Start Date	2025-09-01
Primary Completion	2025-12-22 (estimated)
Study Completion	2026-12-22 (estimated)
Updated on ClinicalTrials.gov	2025-06-29