Summary:
In patients with chronic diabetes-related foot ulcers of at least 4 weeks’ duration, extracorporeal shockwave therapy (ESWT) at either high dose (500 shocks/cm²) or low dose (100 shocks/cm²) demonstrated significantly improved ulcer healing rates over 24 weeks compared to sham ESWT (device application without energy delivery) plus standard wound care, and was associated with only mild-to-moderate local discomfort during treatment and transient skin erythema, with no serious adverse events.
| PICO | Description |
|---|---|
| Population | Patients with diabetes-related foot ulcers of at least 4 weeks’ duration, representing chronic wounds that have failed to progress with standard care alone. |
| Intervention | Extracorporeal shockwave therapy (ESWT) administered at high dose (500 shocks/cm²) or low dose (100 shocks/cm²), delivered in addition to standard wound care protocols including offloading, debridement, and moisture management. |
| Comparison | Sham ESWT (0 shocks/cm² with device application but no energy delivery) plus standard wound care. |
| Outcome | Both active ESWT doses significantly improved ulcer healing rates over 24 weeks compared to sham treatment. Adverse effects were limited to mild-to-moderate local discomfort during treatment and transient skin erythema, with no serious adverse events reported. |
Clinical Context
Diabetic foot ulcers affect approximately 15-25% of patients with diabetes during their lifetime, with 14-24% progressing to amputation. Despite advances in wound care, many DFUs remain refractory to standard treatment, creating urgent need for adjunctive therapies that can accelerate healing and prevent limb loss. Chronic wounds that persist beyond 4 weeks despite appropriate care are particularly challenging and represent the population most likely to benefit from advanced interventions.
Extracorporeal shockwave therapy (ESWT) delivers acoustic pressure waves to tissue, originally developed for lithotripsy but increasingly applied to musculoskeletal and wound healing applications. The proposed mechanisms for wound healing include neovascularization stimulation, increased local blood flow, growth factor release, anti-inflammatory effects, and antibacterial properties. These mechanisms address multiple pathophysiological deficits in diabetic wounds.
Previous ESWT studies in DFU have shown promise but optimal dosing parameters remain undefined. This pilot trial compared high-dose (500 shocks/cm²) versus low-dose (100 shocks/cm²) versus sham ESWT to establish dose-response relationships and inform future definitive trials.
Clinical Pearls
1. Both Doses Effective—Lower Dose May Suffice: The significant healing improvement at both 100 and 500 shocks/cm² suggests even lower-intensity protocols may be clinically effective. Lower doses may offer equivalent benefit with reduced treatment discomfort and shorter session times.
2. Chronic Wounds Respond to Stimulation: Wounds stalled for 4+ weeks showed renewed healing with ESWT, suggesting mechanical stimulation can “restart” the healing process in chronic DFUs. This supports ESWT as a salvage option for wounds failing conservative management.
3. Sham-Controlled Design Confirms True Effect: The sham control (device application without energy delivery) accounts for placebo effects and attention bias. Superior outcomes with active treatment confirm ESWT’s biological effect rather than non-specific benefits of additional wound attention.
4. Favorable Safety Profile: Local discomfort and transient erythema were the only reported adverse effects—both expected and self-limiting. No serious adverse events occurred, supporting ESWT’s safety for DFU application even in patients with diabetes who may have impaired sensation.
Practical Application
Consider ESWT for DFUs that have failed 4+ weeks of appropriate standard care including offloading, debridement, moisture management, and infection control. ESWT is additive therapy—maintain all standard wound care components during treatment. The 24-week healing timeframe suggests patience is required; don’t abandon therapy prematurely.
Starting with lower doses (100 shocks/cm²) is reasonable given efficacy at this intensity; escalate if initial response is inadequate. Treatment sessions are typically brief (15-30 minutes) and can be integrated with routine wound care visits. Warn patients about expected transient discomfort during treatment.
ESWT requires specialized equipment and trained operators. For practices without ESWT capability, consider referral to wound centers offering this modality for appropriate patients. Insurance coverage varies; verify reimbursement before initiating treatment.
Broader Evidence Context
This pilot trial adds to an emerging evidence base for ESWT in diabetic wounds. Previous smaller studies and case series have suggested benefit, but this sham-controlled design provides stronger evidence. Meta-analyses of available ESWT studies generally support efficacy, though heterogeneity in protocols limits definitive conclusions.
ESWT is one of several advanced wound therapies including hyperbaric oxygen, negative pressure wound therapy, growth factors, and biological wound coverings. Comparative effectiveness data between these modalities is limited; treatment selection often depends on availability and individual wound characteristics.
Study Limitations
As a pilot study, sample size limits statistical power and subgroup analyses. Optimal ESWT parameters (number of sessions, treatment intervals, total shock count) remain undefined. Cost-effectiveness data wasn’t reported. The 24-week timeframe may not capture complete healing for all wounds.
Bottom Line
Extracorporeal shockwave therapy at both high and low doses significantly improves healing of chronic diabetic foot ulcers compared to sham treatment. With a favorable safety profile limited to transient local effects, ESWT represents a promising adjunctive therapy for DFUs refractory to standard care.
Source: Hitchman L, et al. “Extracorporeal Shockwave Therapy for Diabetes Related Foot Ulcers: A Pilot Three-Arm Double-Blinded Randomised Controlled Trial.” 2025. Read article
