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

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.