Diabetes complications

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

Diabetes Obes MetabPublished Comparative cohort study

Authors' conclusion

Our study showed significantly longer AFS and lower major amputation rates in patients treated by ACT and re-PTA in contrast to patients treated conservatively. Overall survival was significantly longer only in the re-PTA group. ACT was shown to be effective in long-term limb salvage in people with no-option CLTI.

Study context

Population
Patients with diabetic foot ulcers (DFU) and chronic limb-threatening ischaemia (CLTI) (TcPO2 <30 mmHg after unsuccessful standard revascularization) treated in one foot clinic over 9 years
Participants
130 patients
Exposure
Autologous cell therapy (ACT) vs repeated percutaneous transluminal angioplasty (re-PTA) vs conservative treatment
  • ACTn = 45
  • re-PTAn = 43
  • Controln = 42reference
Outcome
Overall survival, amputation-free survival (AFS) and major amputation rate
Follow-up
7-year follow-up
Methodological detailssingle foot clinic, 7-year follow-up
  • Single foot clinic
  • 7-year follow-up

Main finding

As reported in the abstract

AFS, major amputation and overall survival
  • ACT vs Control: P < 0.001
  • re-PTA vs Control: P < 0.001
  • ACT vs Control: P < 0.001
  • re-PTA vs Control: P < 0.001
  • re-PTA vs Control: P < 0.001
  • ACT vs Control: P = 0.063
  • ACT vs re-PTA: P = 0.081

Observational data: associations, not effects.

Further findings

Baseline angiograms (Graziani and GLASS infrapopliteal) and TcPO2

ACT and control had significantly worse baseline angiograms than re-PTA (both p < 0.001); no differences in baseline TcPO2

Original publication

Long‐term efficacy of autologous cell therapy, repeated PTA and conservative treatment in people with diabetes and chronic limb‐threatening ischaemia. Diabetes Obes Metab. Published 9 June 2025. doi:10.1111/dom.16510

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