SynthesisFrontiers in bioengineering and biotechnology2026
Clinical trials on 3D bioprinted scaffolds for lower extremity vascular, diabetic and pressure ulcers: a systematic review.
Synthesis in Frontiers in bioengineering and biotechnology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
3 authors.
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Abstract
Aim: Three-dimensional (3D) bioprinting enables fabrication of bioink-based scaffolds that mimic native tissue architecture. This systematic review aims to evaluate the safety profile and healing times of 3D-bioprinted scaffolds clinically tested in human lower limb ulcers. Methods: A systematic review was conducted in accordance with PRISMA guidelines. PubMed, Embase, Scopus, and Web of Science were searched from January 2000 to June 2025. Inclusion criteria encompassed only clinical studies; animal, Results: Of 476 records screened, eight studies met the inclusion criteria: two randomized controlled trials and six single-arm studies. 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). Conclusion: 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.
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