Diabetic foot ulcers (DFUs) are among the most consequential complications of diabetes, and a substantial share fail to heal despite good standard care: debridement, offloading, infection control, and vascular assessment. This has driven interest in adjunctive therapies. One of the more widely studied is extracorporeal shockwave therapy (ESWT), in which acoustic pressure pulses are delivered to the wound and surrounding tissue. This article reviews what controlled trials and meta-analyses show, and where the evidence is limited.
What Is Shockwave Therapy and How Might It Work?
ESWT delivers short, high-energy acoustic pulses through a gel-coupled applicator. In wound care, the proposed mechanisms are biological rather than mechanical: stimulation of angiogenesis, modulation of inflammatory signalling, recruitment of progenitor cells, and enhanced growth factor expression. Two delivery approaches have been studied: focused devices, applied over the wound without direct contact, and unfocused (radial) devices. These mechanisms come largely from laboratory and early clinical work, and they have not been established in people with diabetic foot ulcers.
Evidence From Randomized Controlled Trials
The most rigorous clinical data come from two multicentre, double-blinded, sham-controlled phase III trials reported by Snyder and colleagues (Journal of Wound Care, 2018). The trials enrolled 336 adults with neuropathic ulcers (University of Texas grade 1A or 2A) that had not reduced in volume by at least 50% after two weeks of standard care. Participants received standard care plus either focused ESWT (172 patients) or a sham treatment (164 patients).
Complete closure at 20 weeks was 35.5% with ESWT versus 24.4% with sham (p=0.027), and at 24 weeks 37.8% versus 26.2% (p=0.023). The difference at 12 weeks (22.7% versus 18.3%) did not reach statistical significance. A companion analysis of secondary endpoints (Galiano et al., Journal of Wound Care, 2019) reported greater wound area reduction with ESWT (48.6% versus 10.7%) and no increase in pain or infection, with recurrence similar between groups.
An important caveat is that both trials were funded by the device manufacturer, and the study population was selective: neuropathic, non-ischemic, non-infected, superficial-to-moderate ulcers that had already shown a poor response to standard care.
What Do Meta-Analyses Conclude?
An earlier systematic review by Hitchman and colleagues (Annals of Vascular Surgery, 2019) pooled five trials with 255 patients. ESWT was associated with higher odds of complete healing than standard wound care (odds ratio 2.66; 95% CI 1.03–6.87), with a mean time to healing of about 64 days versus 81 days. Comparison with hyperbaric oxygen also favoured ESWT. However, all included studies carried an unclear or high risk of bias, and infection and amputation outcomes were not reported. The authors concluded that the evidence was insufficient to justify routine use.
A more recent meta-analysis by Ruiz Muñoz and colleagues (Medical Sciences, 2025) pooled eight randomized trials with 672 patients and reported a pooled odds ratio for complete healing of 2.75 (95% CI 1.97–3.84), with very low statistical heterogeneity. The authors described ESWT as a valuable adjunct to standard care. Even so, pooled estimates can be inflated when the underlying trials are small, unblinded, or use different device types, energy settings, and treatment schedules, which is the case in this literature.
Where Guidelines and Evidence Gaps Stand
The 2023 IWGDF guideline on interventions to enhance healing of foot ulcers (Diabetes/Metabolism Research and Reviews, 2024) made conditional recommendations for several adjuncts, including sucrose octasulfate dressings, placental-derived products, autologous platelet or leucocyte patches, topical oxygen, and hyperbaric oxygen, each reserved for wounds that fail to heal with optimal standard care. The authors also noted that the overall certainty of evidence remains low and called for fewer, better-designed trials. Shockwave therapy was not listed among the adjuncts receiving a supportive recommendation, which reflects the limits of the available evidence rather than demonstrated harm.
Open questions include the optimal device type, energy level, and number of sessions; whether benefits extend to ischemic, infected, or deeper ulcers; effects on amputation and recurrence; and cost-effectiveness. Independent, adequately powered trials with standardized protocols would help answer these.
Key Takeaways
ESWT is a non-invasive adjunct that, in randomized and pooled data, is associated with higher rates of complete healing of selected neuropathic DFUs that stall under standard care, without a clear increase in pain or infection. The certainty of that evidence is limited by small trials, risk of bias, industry funding, heterogeneous protocols, and a narrow study population. It does not replace the foundations of ulcer care: offloading, debridement, infection management, glycemic control, and revascularization when indicated.
References
- Snyder R, Galiano R, Mayer P, Rogers LC, Alvarez O. Diabetic foot ulcer treatment with focused shockwave therapy: two multicentre, prospective, controlled, double-blinded, randomised phase III clinical trials. J Wound Care. 2018;27(12):822-836.
- Galiano R, Snyder R, Mayer P, Rogers LC, Alvarez O. Focused shockwave therapy in diabetic foot ulcers: secondary endpoints of two multicentre randomised controlled trials. J Wound Care. 2019;28(6):383-395.
- Hitchman LH, Totty JP, Raza A, et al. Extracorporeal shockwave therapy for diabetic foot ulcers: a systematic review and meta-analysis. Ann Vasc Surg. 2019;56:330-339.
- Ruiz Muñoz M, Rueda Zapata L, Martínez Barrios FJ, et al. Efficacy of extracorporeal shockwave therapy in the management of chronic diabetic foot ulcer: a systematic review and meta-analysis. Med Sci (Basel). 2025;13(4):219.
- International Working Group on the Diabetic Foot. Guidelines on interventions to enhance healing of foot ulcers in people with diabetes (IWGDF 2023 update). Diabetes Metab Res Rev. 2024;40(3):e3644.
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