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Background <p>Diabetic foot is a severe complication of diabetes mellitus, with a significant impact on patients’ quality of life. The traditional treatment has been amputation, but its high mortality rate has prompted a search for alternatives, such as the resection of non-viable tissue and limb stabilization using external fixation. This study evaluates the cost-effectiveness relationship between these two strategies.</p> Methods <p>An assessment was made of the incremental cost-effectiveness ratio (ICER), calculated over a ten-year time horizon, of both amputation and external fixation. The analysis was based on clinical and cost data obtained from a previous study and used a discrete event simulation model.</p> Results <p>The mean ten-year quality-adjusted life expectancy for amputated patients was 2.641 ± 1.64 quality-adjusted life years (QALYs) as compared with 6.627 ± 1.46 QALYs for patients treated with external fixation (<i>p</i> &lt; 0.001). The average cost-effectiveness ratio (CER) was estimated at €29,717/QALY for amputation and €15,360/QALY for external fixation. A comparison between both options resulted in an ICER of €5,847/QALY. Sensitivity analyses found ICER values ranging between €5,847/QALY and €12,296/QALY. A budget impact analysis revealed that the incorporation of the new treatment alternative into the Spanish National Health System would lead to a budget increase of €528.2&#xa0;million over a ten-year horizon.</p> Conclusions <p>The use of external fixation in the treatment of ulcerated diabetic foot was shown to be a cost-effective option compared to major amputations.</p>

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External fixation versus amputation in the treatment of ulcerated diabetic foot: a cost-utility analysis using real-world data and a discrete-event simulation model

  • 期刊论文

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  • 发表日期：

    2026年1月3日

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  • Pablo Oscar Roza Miguel,
  • Laia López Capdevila,
  • María Rabanal Rubio,
  • Alejandro Santamaría Fumas,
  • Nuria García-Rodríguez,
  • Eduardo González Fidalgo

摘要

Background

Diabetic foot is a severe complication of diabetes mellitus, with a significant impact on patients’ quality of life. The traditional treatment has been amputation, but its high mortality rate has prompted a search for alternatives, such as the resection of non-viable tissue and limb stabilization using external fixation. This study evaluates the cost-effectiveness relationship between these two strategies.

Methods

An assessment was made of the incremental cost-effectiveness ratio (ICER), calculated over a ten-year time horizon, of both amputation and external fixation. The analysis was based on clinical and cost data obtained from a previous study and used a discrete event simulation model.

Results

The mean ten-year quality-adjusted life expectancy for amputated patients was 2.641 ± 1.64 quality-adjusted life years (QALYs) as compared with 6.627 ± 1.46 QALYs for patients treated with external fixation (p < 0.001). The average cost-effectiveness ratio (CER) was estimated at €29,717/QALY for amputation and €15,360/QALY for external fixation. A comparison between both options resulted in an ICER of €5,847/QALY. Sensitivity analyses found ICER values ranging between €5,847/QALY and €12,296/QALY. A budget impact analysis revealed that the incorporation of the new treatment alternative into the Spanish National Health System would lead to a budget increase of €528.2 million over a ten-year horizon.

Conclusions

The use of external fixation in the treatment of ulcerated diabetic foot was shown to be a cost-effective option compared to major amputations.