Snyder et al. 2020
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Snyder R, Galiano R, Mayer P, Rogers LC, Alvarez O; Sanuwave Trial Investigators. Diabetic foot ulcer treatment with focused shockwave therapy: two multicentre, prospective, controlled, double-blinded, randomised phase III clinical trials. J Wound Care. 2018 Dec 2;27(12):822-836.
Design: Two Multicentre Randomised Control Trials Subjects: 336 subjects with Diabetic foot ulcers (DFUs) that did not reduce in volume by at least 50% over two weeks' standard treatment were included. Methods: Patients with DFUs in both studies were randomised and managed with: 1. Standard care and focused ESWT active therapy (n=172) 2. Standard care and sham treatment (n=164) Treatment was delivered four times over a two-week treatment phase in study 1 and up to eight times over 12 weeks in study 2. Outcomes included: Complete wound closure within 12, 20 and 24 weeks, adverse events at 24 weeks and wound area reduction. Results: • Statistically significantly more DFU healed at 20 (35.5% versus 24.4%; p=0.027) and 24 weeks (37.8% versus 26.2%; p=0.023) in the active treatment arm compared with the sham-controlled arm. • Regarding adverse events, the subjects who used active therapy 18% experienced increased wound size compared with 31.1% in the sham cohort at 12 weeks. • In the pooled dataset, wound area reduction was statistically significantly different in favour of active therapy from week 6 to week 24.
Key message: Extracorporeal shockwave therapy is an effective therapeutic modality in combination with standard care for neuropathic DFU that do not respond to standard care alone.
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