Pharmacist-led interventions for cardiometabolic risk reduction in patients with diabetic foot ulcers and metabolic syndrome: a prospective pilot study

What is it about?

Abstract Background Diabetic foot ulcers (DFUs) in people with type 2 diabetes and metabolic syndrome (MetS) carry high cardiovascular risk. Pharmacist-led care may help, but evidence in this combined population is limited. Objective To assess feasibility and safety, and to explore preliminary impact of pharmacist-led interventions in adults with DFU and MetS. Methods We conducted a prospective single-arm observational cohort at a tertiary hospital (December 2024–May 2025). Interventions included comprehensive medication review, biweekly counseling, lifestyle education, and adverse drug reaction (ADR) monitoring. Outcomes included feasibility (recruitment, retention, tool reliability), clinical endpoints (HbA1c, blood pressure, LDL-C, DFU healing), and medication adherence (MARS-10). Analyses were within-subject (paired tests); p-values were exploratory. Results Of 122 screened, 55 were enrolled (recruitment 45.1%); 49 (89.1%) completed 6-month follow-up. MARS-10 improved from 6.8±1.9 to 8.5±1.3; HbA1c from 8.5±1.4% to 8.0±1.3%; systolic BP from 144±21 to 137±20 mmHg; LDL-C from 126±33 to 115±30 mg/dL (all p≤0.003). DFU remained stable in 95.9%, with 51% complete healing; median time-to-healing was 13 weeks (95% CI 10.4–15.6). Twenty-two ADRs were reported (mostly mild/moderate). Conclusion Pharmacist-led care for adults with DFU and MetS was feasible, acceptable, and deliverable with high fidelity, with encouraging pre–post improvements in adherence, cardiometabolic measures, and wound outcomes. Controlled, multicenter trials are warranted to establish effectiveness and cost-effectiveness.

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