Int J Low Extrem Wounds. 2026 Aug 18:15347346261479522. doi: 10.1177/15347346261479522. Online ahead of print.
ABSTRACT
Recurrence of diabetic foot ulcer (DFU) remains a major clinical challenge in patients with diabetes. Therapeutic footwear is a cornerstone of secondary prevention as it reduces plantar pressure and mechanical stress. However, most available evidence focuses on traditional orthopedic footwear, while prospective data on therapeutic sport footwear designed for daily physical activities are poor. This study aimed to evaluate the effectiveness of therapeutic sport footwear with a semi-rigid biomechanical sole (termed YDA) with combined insole in preventing ulcer recurrence in patients with diabetes at high risk of re-ulceration. The study was a single-arm, uncontrolled, retrospective observational study including consecutive patients with diabetes and a history of DFU referred to a tertiary diabetic foot center between January 2024 and March 2025. All included patients wore YDA as therapeutic footwear during the study period. In addition, they were managed through a multidisciplinary protocol including regular clinical follow-up, risk-factor monitoring, and structured patient education. The 1-year outcomes included: ulcer recurrence, minor and major amputations. Overall, 47 patients were included (68.1% male; mean age 68.3 ± 8.4 years). Peripheral neuropathy was present in all patients and peripheral arterial disease in 55.3%. At 1 year of follow-up, ulcer recurrence occurred in 14.9% of patients, minor amputation in 6.4%, and no major amputations were recorded. The multivariate analysis showed that discontinuous use of therapeutic footwear was strongly associated with ulcer recurrence (OR 8.9, 95% CI 2.1-37.5; p < 0.0001) and minor amputation (OR 10.5, 95% CI 2.0-55; p = 0.004). Peripheral arterial disease was independently associated with minor amputation (OR 5.2, 95% CI 1.3-20.6; p = 0.02). The use of specific sport footwear with a semi-rigid biomechanical sole resulted in a low rate of re-ulceration.
PMID:42610825 | DOI:10.1177/15347346261479522