Nanomedicine Journal

Nanomedicine Journal

The safety and efficacy of platelet-derived exosomes for grade II diabetic foot ulcers in a phase I clinical trial

Articles in Press

Document Type : Research Paper

Authors
Asma Maleki 1
Ensieh Nasli Esfahani 2
Mina Soufi Zoomorrod 1
Shaban Alizadeh 3
Camelia Rambod 4
Melina Rezvani 2
Masoud Soleimani 1
1 Department of Hematology, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran
2 Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran
3 Department of Hematology, Faculty of Medical Sciences, Tehran University of medical scinces, Tehran, Iran
4 Evidence Based Medicine Research Center, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran
10.22038/nmj.2026.94692.2401
Abstract
Objective(s): Exosomes are extracellular vesicles derived from various cell types. Platelet-derived exosomes contain growth factors and cytokines that contribute to tissue repair. This study assessed the safety and efficacy of platelet-derived exosomes in treating diabetic foot ulcers.
Materials and Methods: Platelet-derived exosomes were isolated by ultracentrifugation and subsequently characterized. Fourteen patients with diabetes and grade II diabetic foot ulcers were included in the study based on the inclusion and exclusion criteria. Exosome injections at a concentration of 50 µg/ml and a volume of 1.5 ml were administered at one-week intervals. Safety and efficacy were assessed through clinical evaluation, measurements of wound dimensions, and laboratory analyses.
Results: No significant adverse clinical events or changes in laboratory test results were observed after exosome injection in the patients. None of the patients' wounds in the control group healed completely within one month. However, a decrease in wound size was observed in 3 patients in the control group. In the intervention group, the wounds of two patients completely closed within one month after PLT-Exo injection, and the wound dimensions of 42.85% of the patients exhibited a decreasing trend.
Conclusion: Diabetic foot ulcers remain a significant wound-healing challenge among affected patients. Because limb amputation has serious consequences, these ulcers require considerable attention, and current treatment modalities often fail. The present study highlighted the safety, efficacy, and clinical feasibility of platelet-derived exosomes. For wider clinical application, further studies under varied conditions and with larger patient groups are recommended.
Keywords
Diabetic foot ulcers
Exosome
Extracellular vesicles
wound healing
Subjects
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Nanomedicine Journal

Articles in Press, Accepted Manuscript
Available Online from 22 September 2026