Summary: In a pilot trial whose main aim was to test whether a full trial could be delivered, extracorporeal shockwave therapy for diabetic foot ulcers showed a descriptive trend toward faster healing at the higher dose, but the study was not designed or powered to prove healing efficacy.
PICO Summary
| Element | Detail |
|---|---|
| Population | 74 recruited patients with a diabetes-related foot ulcer present ≥4 weeks (from 141 eligible); pilot, double-blind, three-arm RCT, UK. |
| Intervention | High-dose (500 shocks/cm²) or low-dose (100 shocks/cm²) extracorporeal shockwave therapy plus standard care. |
| Comparison | Sham (0 shocks/cm²) plus standard care; follow-up 24 weeks. |
| Outcome | The primary outcome was trial deliverability: 52.5% of eligible patients were recruited and follow-up attendance was 88–97%. Median healing time was descriptively shorter with high dose (54.0 days) than low dose (78.5) or sham (83.0), but the pilot was not powered to test this. The EQ-5D-5L utility at 24 weeks was actually lowest in the high-dose arm (0.621 vs 0.806 sham). Healthcare resource use was lowest with low-dose ESWT. |
Expert Commentary
This study must be read for what it actually is, a feasibility pilot whose stated primary aim was to determine whether a definitive trial of shockwave therapy for diabetic foot ulcers can be delivered, not to prove that it heals ulcers. On that primary question it succeeded, showing that patients are willing to take part and that follow-up is achievable, which is genuinely useful groundwork. The healing data, by contrast, are descriptive only: median healing was numerically shorter with the higher dose, but the trial was deliberately not powered for efficacy, so this is a hypothesis to test rather than a demonstrated benefit, and it should not be presented as a significant improvement over sham. Two honest details complicate any optimistic reading, the quality-of-life utility was actually lowest in the high-dose arm, and resource use was lowest with the low dose, so the dose-response picture is not clean. Can I use this with my patients? Not yet as a treatment decision. Shockwave therapy remains investigational for diabetic foot ulcers, and this pilot’s real contribution is to justify and design a properly powered trial, while offloading, debridement, infection control, perfusion, and glycaemic management remain the foundation of care.
References
Hitchman L, Lathan R, Ravindhran B, et al. Extracorporeal shockwave therapy for diabetes related foot ulcers: a pilot three-arm double-blinded randomised controlled trial. Int Wound J. 2025;22(12):e70740. doi:10.1111/iwj.70740