Table 2_Clinical trials on 3D bioprinted scaffolds for lower extremity vascular, diabetic and pressure ulcers: a systematic review.docx

The combined sample size across all studies was 139 patients. Both RCTs reported a statistically significant reduction in time to complete epithelialization versus standard dressings. In the single-arm studies, >80% of ulcers achieved complete epithelialization within 12 weeks.

No treatment-related serious adverse events were reported. Risk-of-bias assessments identified methodological limitations across studies (variable randomization and blinding, small sample sizes, and limited follow-up).</p>Conclusion<p>Current clinical evidence indicates that 3D-bioprinted scaffolds, particularly Autologous Minimally Manipulated Homologous Adipose Tissue (AMHAT) and polylactic-acid gelatin constructs, represent a promising and apparently safe approach to accelerate ulcer healing and improve cosmetic outcomes.

However, the number of patients included in each study were small with relatively short follow-up. Larger, high-quality randomized trials with longer follow-up are needed to confirm efficacy and long-term safety.</p>