Long-term efficacy of autologous cell therapy, repeated PTA and conservative treatment in people with diabetes and chronic limb threatening ischemia

Aim: Data about long-term clinical outcomes of revascularization procedures, especially for 
autologous cell therapy (ACT), in diabetic patients with chronic limb-threatening ischemia (CLTI) is 
lacking. The aim of our study was to compare the mortality and amputation rates in patients with 
diabetic foot ulcers (DFU) and CLTI treated by ACT with patients treated by repeated percutaneous 
transluminal angioplasty (re-PTA) and patients treated conservatively.
 Method: One-hundred and thirty patients with DFU and CLTI (defined as transcutaneous oxygen 
pressure – TcPO2˂35mmHg after unsuccessful standard revascularization) treated in our foot clinic 
over 9 years were enrolled into the study. Forty-five patients were treated by ACT, 43 patients 
underwent re-PTA and 42 patients were treated conservatively and formed the control group. Overall 
survival, amputation-free survival (AFS) and major amputation rate were assessed over 7-year follow
up period.
 Results/Discussion: Patients in all groups did not differ significantly in baseline demographic 
characteristics or comorbidities. Patients in ACT and control groups had significantly worse baseline 
angiograms in accordance with Graziani and GLASS (infrapopliteal region) classifications than re
PTA group (both p˂0.001), but there were no differences in baseline values of TcPO2 among all 
groups. The rate of major amputation after 7 years was significantly lower in ACT and re-PTA groups 
in comparison with control group (p=0.007 and p=0.001), similar results were observed in AFS – both 
active groups proved significantly longer AFS compared to control (p=0.008 and p=0.003). Re-PTA 
group showed significantly longer overall survival compared to ACT and control groups (p=0.045 and 
0.009). 
Conclusion: Our study showed significantly lower amputation rates and longer AFS in patients 
treated by ACT and re-PTA in contrast to patients treated conservatively. Overall survival was 
significantly longer in re-PTA group. ACT proved to be long-term effective treatment of CLTI.