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The Management of Diabetic Foot Ulcers with Porcine Small Intestine Submucosa Tri-Layer Matrix: A Randomized Controlled Trial
Abstract
Objective: This study demonstrates that superior outcomes are possible when diabetic foot ulcers (DFU) are managed with tri-layer porcine small intestine submucosa (SIS). Approach: Patients with DFU from 11 centers participated in this prospective randomized controlled trial. Qualified subjects were randomized (1:1) to either SIS or standard care (SC) selected at the discretion of the Investigator and followed for 12 weeks or complete ulcer closure. Results: Eighty-two subjects (41 in each group) were evaluable in the intent-to-treat analysis. Ulcers managed with SIS had a significantly greater proportion closed by 12 weeks than for the Control group (54% vs. 32%, p =0.021) and this proportion was numerically higher at all visits. Time to closure for ulcers achieving closure was 2 weeks earlier for the SIS group than for SC. Median reduction in ulcer area was significantly greater for SIS at each weekly visit (all p values<0.05). Review of reported adverse events found no safety concerns. Innovation: These data support the use of tri-layer SIS for the effective management of DFU. Conclusion: In this randomized controlled trial, SIS was found to be associated with more rapid improvement, and a higher likelihood of achieving complete ulcer closure than those ulcers treated with SC.
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“Although the final follow-up wound area was similar between two treatment groups, the percentage area reduction (PAR) was demonstrated to be significantly increased in several studies [23, 26, 27, 31, 34].”
From Effectiveness and safety of dermal matrix used for diabetic foot ulcer: a systematic review and meta-analysis of randomized controlled trials (2024) · cites this paper as [34]
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Research works printed but not linked: 21
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Cited by
Extracellular matrix-inspired biomaterials for wound healing
Hosty, L., Heatherington, T., Quondamatteo, F., & Browne, S. (2024) · Molecular Biology Reports · doi:10.1007/s11033-024-09750-9 · Cited by 63
Mohammed, Y. A., Farouk, H. K., Gbreel, M. I., Ali, A. M., Salah, A. A., Nourelden, A. Z., & Gawad, M. M. A. (2022) · Journal of Foot and Ankle Research · doi:10.1186/s13047-022-00575-y · Cited by 36
Sui, L., Xie, Q., Jiang, H.-T., & Li, X.-D. (2024) · BMC Endocrine Disorders · doi:10.1186/s12902-024-01550-3 · Cited by 14
Immune Response to Extracellular Matrix Bioscaffolds: A Comprehensive Review
Romero, D. J., Hussey, G., & Capella-Monsonís, H. (2025) · Biologics · doi:10.3390/biologics5030028 · Cited by 7
“Furthermore, SIS-derived ECM has been employed in both preclinical and clinical settings for decades without reports of significant adverse immunological events [72,141–144].”
Metadata
- Authors
- Cazzell, S. M., Lange, D. L., Dickerson, J. E., & Slade, H. B.
- Venue
- Advances in Wound Care
- Publisher
- SAGE Publications
- Published
- 2015-12
- Volume
- 4
- Issue
- 12
- Pages
- 711-718
- ISSN
- 2162-1918
- 2162-1934
- Cited by
- 60
- References
- 0
- Language
- en
- Licence
- creativecommons.org/licenses/by/4.0/ (vor)
- journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
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- CoChat. (2026). Citation check: The Management of Diabetic Foot Ulcers with Porcine Small Intestine Submucosa Tri-Layer Matrix: A Randomized Controlled Trial. https://app.cochat.ai/papers/10.1089/wound.2015.0645
- The paper
- Cazzell, S. M., Lange, D. L., Dickerson, J. E., & Slade, H. B. (2015). The Management of Diabetic Foot Ulcers with Porcine Small Intestine Submucosa Tri-Layer Matrix: A Randomized Controlled Trial. Advances in Wound Care. https://doi.org/10.1089/wound.2015.0645
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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
