Abstract
Background
Diabetic foot ulcer (DFU) is a major cause of infection-related hospitalization and amputation. Negative-pressure wound therapy with instillation and dwell time (NPWTi-d) is used for complex DFU, and beraprost sodium (BS), an oral prostacyclin analogue, may improve microcirculation; evidence for their combination is limited.
Objective
To assess the safety and effectiveness of NPWTi-d plus BS versus NPWTi-d alone and BS with standard wound care in DFU.
Methods
We retrospectively reviewed hospitalized DFU patients treated from February 2019 to April 2024. Of 667 screened patients, 590 met inclusion criteria and were grouped by therapy: NPWTi-d (n = 190), BS plus standard care (n = 200), and NPWTi-d plus BS (n = 200). Primary outcomes were 12-week healing rate, time to healing, and ulcer area reduction (ImageJ). Secondary outcomes included reinfection and DFU-related readmission at 12 weeks, 6 months, and 12 months, and quality of life (DFU-SF).
Results
At 12 weeks, NPWTi-d plus BS achieved faster healing than NPWTi-d alone (mean difference 2.6 days; 95% CI 0.1-5.3; P = 0.042) and greater area reduction at weeks 8–12 (P < 0.05). DFU-SF improved in all groups, with consistently higher scores in the combination group (P < 0.001). Reinfection and readmission increased over time in all groups; between-group differences were small and may reflect residual confounding. No treatment-related serious adverse events were documented. No major bleeding, symptomatic hypotension, or treatment discontinuation due to intolerance was documented during the 12-week treatment period; minor adverse events may be underreported due to the retrospective design.
Conclusions
In this retrospective cohort, adding oral BS to NPWTi-d was associated with faster wound closure and better DFU-related quality of life. Prospective controlled studies are needed to confirm these findings.
Keywords
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