Peripheral Blood Mononuclear Cells: A New Frontier in the Management of Patients with Diabetes and No-Option Critical Limb Ischaemia
The current study aimed to evaluate the effectiveness of peripheral blood mononuclear cell (PB-MNC) therapy as adjuvant treatment for patients with diabetic foot ulcers (DFUs) and no-option critical limb ischaemia (NO-CLI). The study is a prospective, noncontrolled, observational study including pat...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-09-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/12/19/6123 |
| _version_ | 1797575693174833152 |
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| author | Marco Meloni Laura Giurato Aikaterini Andreadi Ermanno Bellizzi Alfonso Bellia Davide Lauro Luigi Uccioli |
| author_facet | Marco Meloni Laura Giurato Aikaterini Andreadi Ermanno Bellizzi Alfonso Bellia Davide Lauro Luigi Uccioli |
| author_sort | Marco Meloni |
| collection | DOAJ |
| description | The current study aimed to evaluate the effectiveness of peripheral blood mononuclear cell (PB-MNC) therapy as adjuvant treatment for patients with diabetic foot ulcers (DFUs) and no-option critical limb ischaemia (NO-CLI). The study is a prospective, noncontrolled, observational study including patients with neuro-ischaemic DFUs and NO-CLI who had unsuccessful revascularization below the ankle (BTA) and persistence of foot ischaemia defined by TcPO2 values less than 30 mmHg. All patients received three cycles of PB-MNC therapy administered through a “<i>below-the-ankle approach</i>” in the affected foot along the wound-related artery according to the angiosome theory. The primary outcome measures were healing, major amputation, and survival after 1 year of follow-up. The secondary outcome measures were the evaluation of tissue perfusion by TcPO2 and foot pain defined by the numerical rating scale (NRS). Fifty-five patients were included. They were aged >70 years old and the majority were male and affected by type 2 diabetes with a long diabetes duration (>20 years); the majority of DFUs were infected and nearly 90% were assessed as gangrene. Overall, 69.1% of patients healed and survived, 3.6% healed and deceased, 10.9% did not heal and deceased, and 16.4% had a major amputation. At baseline and after PB-MNC therapy, the TcPO2 values were 17 ± 11 and 41 ± 12 mmHg, respectively (<i>p</i> < 0.0001), while the pain values (NRS) were 6.8 ± 1.7 vs. 2.8 ± 1.7, respectively (<i>p</i> < 0.0001). Any adverse event was recorded during the PB-MNC therapy. Adjuvant PB-MNC therapy seems to promote good outcomes in patients with NO-CLI and neuro-ischaemic DFUs. |
| first_indexed | 2024-03-10T21:42:53Z |
| format | Article |
| id | doaj.art-8aba81970b424b5b8786940af98a1474 |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-10T21:42:53Z |
| publishDate | 2023-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Clinical Medicine |
| spelling | doaj.art-8aba81970b424b5b8786940af98a14742023-11-19T14:34:24ZengMDPI AGJournal of Clinical Medicine2077-03832023-09-011219612310.3390/jcm12196123Peripheral Blood Mononuclear Cells: A New Frontier in the Management of Patients with Diabetes and No-Option Critical Limb IschaemiaMarco Meloni0Laura Giurato1Aikaterini Andreadi2Ermanno Bellizzi3Alfonso Bellia4Davide Lauro5Luigi Uccioli6Department of Systems Medicine, University of Rome “Tor Vergata”, 00133 Rome, ItalyDivision of Endocrinology and Diabetes, CTO Andrea Alesini Hospital, 00145 Rome, ItalyDepartment of Systems Medicine, University of Rome “Tor Vergata”, 00133 Rome, ItalyDepartment of Systems Medicine, University of Rome “Tor Vergata”, 00133 Rome, ItalyDepartment of Systems Medicine, University of Rome “Tor Vergata”, 00133 Rome, ItalyDepartment of Systems Medicine, University of Rome “Tor Vergata”, 00133 Rome, ItalyDivision of Endocrinology and Diabetes, CTO Andrea Alesini Hospital, 00145 Rome, ItalyThe current study aimed to evaluate the effectiveness of peripheral blood mononuclear cell (PB-MNC) therapy as adjuvant treatment for patients with diabetic foot ulcers (DFUs) and no-option critical limb ischaemia (NO-CLI). The study is a prospective, noncontrolled, observational study including patients with neuro-ischaemic DFUs and NO-CLI who had unsuccessful revascularization below the ankle (BTA) and persistence of foot ischaemia defined by TcPO2 values less than 30 mmHg. All patients received three cycles of PB-MNC therapy administered through a “<i>below-the-ankle approach</i>” in the affected foot along the wound-related artery according to the angiosome theory. The primary outcome measures were healing, major amputation, and survival after 1 year of follow-up. The secondary outcome measures were the evaluation of tissue perfusion by TcPO2 and foot pain defined by the numerical rating scale (NRS). Fifty-five patients were included. They were aged >70 years old and the majority were male and affected by type 2 diabetes with a long diabetes duration (>20 years); the majority of DFUs were infected and nearly 90% were assessed as gangrene. Overall, 69.1% of patients healed and survived, 3.6% healed and deceased, 10.9% did not heal and deceased, and 16.4% had a major amputation. At baseline and after PB-MNC therapy, the TcPO2 values were 17 ± 11 and 41 ± 12 mmHg, respectively (<i>p</i> < 0.0001), while the pain values (NRS) were 6.8 ± 1.7 vs. 2.8 ± 1.7, respectively (<i>p</i> < 0.0001). Any adverse event was recorded during the PB-MNC therapy. Adjuvant PB-MNC therapy seems to promote good outcomes in patients with NO-CLI and neuro-ischaemic DFUs.https://www.mdpi.com/2077-0383/12/19/6123diabetesdiabetic footcritical limb ischaemiacell therapy |
| spellingShingle | Marco Meloni Laura Giurato Aikaterini Andreadi Ermanno Bellizzi Alfonso Bellia Davide Lauro Luigi Uccioli Peripheral Blood Mononuclear Cells: A New Frontier in the Management of Patients with Diabetes and No-Option Critical Limb Ischaemia Journal of Clinical Medicine diabetes diabetic foot critical limb ischaemia cell therapy |
| title | Peripheral Blood Mononuclear Cells: A New Frontier in the Management of Patients with Diabetes and No-Option Critical Limb Ischaemia |
| title_full | Peripheral Blood Mononuclear Cells: A New Frontier in the Management of Patients with Diabetes and No-Option Critical Limb Ischaemia |
| title_fullStr | Peripheral Blood Mononuclear Cells: A New Frontier in the Management of Patients with Diabetes and No-Option Critical Limb Ischaemia |
| title_full_unstemmed | Peripheral Blood Mononuclear Cells: A New Frontier in the Management of Patients with Diabetes and No-Option Critical Limb Ischaemia |
| title_short | Peripheral Blood Mononuclear Cells: A New Frontier in the Management of Patients with Diabetes and No-Option Critical Limb Ischaemia |
| title_sort | peripheral blood mononuclear cells a new frontier in the management of patients with diabetes and no option critical limb ischaemia |
| topic | diabetes diabetic foot critical limb ischaemia cell therapy |
| url | https://www.mdpi.com/2077-0383/12/19/6123 |
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