Role of intravenous alprostadil therapy in patients with below- knee no-option chronic limb-threatening ischemia (NO-CLTI) and diabetes mellitus: A single-center prospective observational study

Aim: To evaluate the clinical outcomes associated with intravenous alprostadil therapy in diabetic patients with below-knee No-Option Chronic Limb-Threatening Ischemia (NO-CLTI).

Material and Methods: This prospective observational study was conducted in the Department of Cardiovascular Surgery, Dhaka Medical College Hospital, Bangladesh, between January 2021 and December 2025. Ninety-four consecutive diabetic patients with angiographically confirmed below-knee NO-CLTI were enrolled.. All patients received optimal medical therapy, wound care, infection control, and six cycles of intravenous alprostadil therapy. Clinical outcomes were assessed using Numerical Rating Scale (NRS) pain scores, Rutherford classification, Fontaine classification, Wagner grading, inflammatory markers, wound-healing status, amputation outcomes, and limb salvage rates during follow-up.

Results: The mean age was 54.2 ± 8.1 years, and 83 patients (88.3%) were male. Significant reductions in ischemic pain were observed during follow-up, with mean NRS pain scores decreasing from 8.1 ± 1.5 at baseline to 2.3 ± 1.7 at seven months (p < 0.001). Significant improvements were also observed in Rutherford and Fontaine classifications (both p < 0.001). The erythrocyte sedimentation rate decreased significantly during follow-up (p = 0.018). Complete resolution of ischemic rest pain was achieved in 47 patients (50.0%). Complete wound healing occurred in 18 patients (19.1%), while 35 patients (37.2%) developed healthy granulation tissue and subsequently underwent reconstructive procedures. Limb salvage was achieved in 83 patients (88.3%), whereas major amputation was required in 11 patients (11.7%). No serious treatment-related adverse events were observed.

Conclusion: Intravenous alprostadil therapy, administered alongside comprehensive wound care and optimal medical management, was associated with significant reductions in ischemic pain, improvement in clinical severity, and a high limb salvage rate (88.3%) among diabetic patients with below-knee chronic limb-threatening ischemia unsuitable for revascularization. These findings suggest that alprostadil may represent a useful adjunctive therapy in carefully selected patients.