Efficacy and safety of oral pentoxifylline and aspirin in chronic venous and arterial leg ulcers: A 12-week randomized controlled trial
DOI:
https://doi.org/10.66344/jpad.v36i1.3342Keywords:
leg ulcers, aspirin, pentoxifylline, ulcer sizeAbstract
Background Chronic Venous and arterial leg ulcers are long-lasting wounds that significantly impair quality of life due to slow healing and recurrent nature. Several studies reported therapeutic role of aspirin and pentoxifylline individually, direct comparison of their efficacy remains limited. Objective To evaluate and compare the wound-healing efficacy, safety, and tolerability of oral aspirin and pentoxifylline in the management of patients with chronic leg ulcers. Methods The 12-week two-arm parallel randomized controlled trial included 62 patients with chronic venous, arterial, or mixed leg ulcers of ≥6 weeks’ duration, of whom 60 completed the study. Patients were randomly allocated into two groups, one group received oral aspirin 300 mg twice daily, while the other received oral pentoxifylline 400 mg twice daily. All participants received standardized wound care. Data were statistically analyzed using Mann-Whitney U test for continuous variables and chi-square tests for categorical variables. A p-value of <0.05 was considered statistically significant. Results Both groups exhibited a significant decrease in ulcer size over time. However, participants receiving oral pentoxifylline showed a substantial reduction compared to those receiving aspirin at 1 month (p=0.001), 2 months, and 3 months (p=0.001). Baseline pain scores were comparable between groups (p=0.789), but the pentoxifylline group demonstrated greater reduction at 2 months (p=0.007). Both groups displayed minimal pain scores after three months (p=0.293). Adverse events were also infrequent and did not show significant variation between treatment groups (p>0.05). Conclusion Pentoxifylline proved to be more effective than aspirin in accelerating ulcer healing and reducing pain in patients with chronic leg ulcers and maintaining a favorable safety profile. The observed outcomes validate its application as a treatment alternative, particularly in cases where compression therapy is unsuitable or poorly tolerated.References
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