An Early Trial-Based Cost-Effectiveness Analysis of Extracorporeal Shockwave Therapy for Diabetes Related Foot Ulcer Healing.

Diabetes related foot ulcers (DFUs) cause significant morbidity and mortality. Extracorporeal shockwave therapy (ESWT) is a promising adjunct to promote healing. This study aimed to explore the potential cost-effectiveness of ESWT in DFU healing. Early model-based cost-effectiveness analysis was undertaken. A de novo four-state, 1-day cycle, Markov model was developed. The perspective for the analysis was the UK's National Health Service (NHS) and Personal Social Services over a 1-year time horizon. Input parameters were estimated from the literature. Low dose ESWT, high dose ESWT and standard care alone were evaluated by running a simulation of 1000 patients with one DFU. Deterministic, probabilistic and value of information analysis were undertaken. Deterministic analysis indicated high dose ESWT has the potential to be a dominant strategy (i.e., no incremental analysis was necessary), exhibiting higher QALYs and lower costs compared to low dose ESWT and standard care. The mean difference in QALYs and costs between high dose ESWT and standard care were 0.022 QALYs and a £922 cost reduction. Preliminary probabilistic analysis, using a threshold of £20 000 per QALY, estimated a 60.2% probability of high dose ESWT being cost-effective compared to standard care. The value of eliminating uncertainty in the model (EVPI) was estimated at £24.56 per patient, with high dose efficacy (partial EVPI per patient £7.87) and health-related quality of life (HRQoL) scores (partial EVPI per patient £3.56) identified as specific areas for future research. This study suggests that ESWT could be a dominant adjunct to aid DFU healing. A definitive study is warranted to estimate ESWT's effectiveness and related HRQoL scores.