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May 29, 2026Diabetes Metabolic Syndrome and Obesity0 citationsOpen Access

Clinical Outcomes and Safety of Stem Cell Therapy for Diabetic Foot Ulcers: A Cross-Sectional Analysis of Overlapping Meta-Analyses

YDYing DuZXZhendong XuTWTianlin Wen

Key Points

  • The study aims to compare the efficacy of stem cell therapies to conventional treatments for diabetic foot ulcers by analyzing existing meta-analyses.
  • Systematic search for meta-analyses comparing stem cell and conventional treatments for DFUs.
  • Methodological quality assessed using Oxford Levels of Evidence and AMSTAR.
  • Data abstraction and evaluation were performed independently using the Jadad decision algorithm.
  • Nine meta-analyses included with five categorized as Level II evidence and four as Level III evidence.
  • Improved ulcer healing rates (P < 0.0001), greater pain-free walking distance (P < 0.00001), and lower amputation rates (P < 0.0001) noted in stem cell groups.
  • Lower incidence of adverse events in stem cell groups compared to conventional treatments (P < 0.001).

Abstract

Purpose: The care of diabetic foot ulcers (DFU) continues to be a notable clinical challenge. The efficacy and safety of stem cell therapies versus conventional treatments for DFU are debated. Cross-sectional analyses of meta-analyses enable structured comparisons of overlapping reviews, facilitate the identification of inconsistencies, and support evidence-based decision-making when conclusions differ. This study aimed to conduct a cross-sectional analysis of existing meta-analyses comparing stem cell and conventional treatments for DFU outcomes to identify the highest-quality available evidence and clarify areas of consistency and discrepancy. Methods: We systematically searched for meta-analyses that investigated stem cell therapies versus conventional treatments for DFU. The complete electronic search strategies for all databases are provided in accordance with PRISMA 2020 recommendations. Methodological quality was assessed using the Oxford Levels of Evidence and original AMSTAR instrument. Data abstraction and quality evaluation were performed independently, and the Jadad decision algorithm was applied to determine the meta-analysis providing the most methodologically robust evidence. Results: Nine meta-analyses were included in this study. Five were categorized as Level II evidence, while the remaining four were classified as Level III evidence. The AMSTAR scores ranged from 7 to 10 (median 9). The Jadad algorithm identified the most robust meta-analysis consistently showing improved ulcer healing rates ( P < 0.0001), greater pain-free walking distance ( P < 0.00001), lower amputation rates ( P < 0.0001) compared with conventional treatments. Furthermore, the incidence of adverse events in the stem cell groups was lower compared to conventional treatments ( P < 0.001). Conclusion: The study indicated that stem cell therapy appeared to be a promising therapeutic option for improving clinical outcomes. However, conclusions should be interpreted with caution due to overlapping primary studies, heterogeneity, and the secondary nature of this cross-sectional evaluation. Moreover, no clear evidence of increased serious adverse events was identified in the highest-quality meta-analysis. The infographic presents a three-part analysis of stem cell therapy for diabetic foot ulcers. The first section, titled ’The Problem: Conflicting Evidence’, highlights that multiple meta-analyses yield contradictory conclusions, with some reporting improved outcomes and others finding no significant difference. The second section, ’The Process: Our Critical Appraisal’, describes a systematic filter that includes nine meta-analyses, AMSTAR quality assessment, Jadad decision algorithm and identifies the highest quality evidence. The third section, ’The Conclusion: Harmonized Evidence’, provides a clear clinical directive based on the best evidence from Huang L et al. (2023), showing superior ulcer healing rates with a significance of less than 0.0001, lower amputation rates with a significance of less than 0.0001, increased pain-free walking distance and a favorable safety profile.Infographic on stem cell therapy for DFUs: conflicting evidence, systematic appraisal and harmonized conclusion. Keywords: diabetic foot ulcer, stem cell therapy, conventional treatment, meta-analysis, Jadad decision algorithm

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Cite This Study

Du et al. (2026) studied this question.

synapsesocial.com/papers/6a192ee7fab5b468c44183d1https://doi.org/10.2147/dmso.s593437
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