Effectiveness of autologous mononuclear cells as adjuvant therapy in patients with ischaemic diabetic foot ulcers receiving indirect lower limb revascularization

Abstract

Aim

The current study aimed to evaluate the effectiveness of peripheral blood mononuclear cells (PB-MNCs) therapy for patients with ischaemic diabetic foot ulcers (DFUs) treated through indirect revascularization.

Methods

The study is a prospective non-controlled observational study including patients with neuro-ischaemic DFUs who received indirect peripheral revascularization and showed a persistence of wound ischaemia defined by the absence of angiographic collateral vessels and TcPO2 values < 30 mmHg in the wound angiosome area. All patients received 3 cycles of PB-MNCs therapy administered along the wound related artery based on the angiosome theory. The primary outcomes measures were healing, major amputation, and survival after 1 year of follow-up. The secondary outcomes measures were the evaluation of tissue perfusion by TcPO2 and foot pain defined by the Numerical Rating Scale (NRS).

Results

Overall 52 (9.7%) patients were included. Most patients were aged (> 70 years), all of them were affected by Type 2 Diabetes with a long diabetes duration (> 20 years). Almost 80% were assessed as grade 2D- 3D of Texas University Classification. Forty-four patients (84.6%) patients healed and survived, 2 (3.85%) healed and deceased, 2 (3.85%) not healed and deceased, 4 (7.7%) not healed and survived. No major amputations were recorded. A significant increase of TcPO₂ after PB-MNCs therapy were recorded in comparison to the baseline (43 ± 9 vs 18 ± 8 mmHg, p < 0.0001), such as a concomitant reduction of foot pain (1.8 ± 1.2 vs 6.2 ± 2.1, p < 0.0001).

Conclusions

PB-MNCs resulted effective to promote wound healing and limb salvage in diabetic patients with ischaemic DFUs who received indirect revascularization.