Predictive factors of major amputation in patients with diabetic foot ulcers treated by peripheral blood mononuclear cells.

Aim: Peripheral blood mononuclear cells (PB-MNCs) therapy is an adjuvant treatment for patients with ischaemic diabetic foot ulcers (DFUs) and no-option critical limb ischemia (NO-CLI). This study aimed to evaluate factors influencing the effectiveness of PB-MNC therapy.

Method: This prospective, not controlled study included a cohort of patients with DFUs and NO-CLI treated by PB-MNCs. NO-CLI was defined as the revascularization failure with desert foot (absence of any artery below-the-ankle) or partial desert foot (absence of a wound-related artery with TcPO₂ < 30 mmHg) at the final post-procedural angiogram. After one year of follow-up, the rate of major amputation was evaluated such as clinical, wound, and vascular features of amputees in comparison to not amputees. In addition, the factors influencing the risk of major amputation were analyzed.

Results/discussion: Sixty-four patients were included. The mean age was 73.8 ± 5.8 years, 75% were male, and all of them had type 2 diabetes. At one year of follow-up, major amputation was documented in 12.5% of patients. Amputees had a higher rate of desert foot (vs. partial desert foot) (100% vs. 25%, p < 0.0001), higher post-procedural pain (5.7 ± 1.9 vs. 2.2 ± 1.3, p < 0.0001), lower TcPO₂ after PB-MNCs therapy (30 ± 8 vs. 43 ± 8 mmHg, p = 0.0001), and more cases of heel ulcers (75% vs. 21.4%, p = 0.002). Independent predictors of major amputation resulted the presence of desert foot, persistence of post-procedural pain, heel involvement with multiple ulcers, and inability to stand or walk without assistance.

Conclusion: PB-MNCs therapy resulted less effective in patients with complete desert foot, persistence of paint after therapy, heel involvement in persons with multiple ulcers, and impaired walking.