Galiano et al. 2019
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Galiano R, Snyder R, Mayer P, Rogers LC, Alvarez O; Sanuwave Trial Investigators. Focused shockwave therapy in diabetic foot ulcers: secondary endpoints of two multicentre randomised controlled trials. J Wound Care. 2019 Jun 2;28(6):383-395.
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 4 times over a two-week treatment phase in study 1 and up to 8 times over 12 weeks in study 2. Outcomes included: Change in target ulcer area, time to wound closure, rate of wound closure, mean wound area reduction, recurrence and amputation. Results: • At 12-weeks, wound area reduction (48.6% versus 10.7%, p=0.015) and perimeter reduction (46.4% versus 25.0%, p=0.022) were significantly greater in the active therapy group compared with the sham-treated group, respectively. • The difference in time to wound closure was significantly in favour of the active therapy group compared to the sham group (84 days versus 112 days for 25% of subjects to reach wound closure respectively; p=0.0346). • Wound area reduction from baseline at week 12 of ≥90% was significantly higher in the active therapy group. • Amputation was insignificantly higher in the sham-treated group and recurrence did not differ.
Key message: Extracorporeal shockwave therapy (ESWT) used adjunctively with standard care leads to more effective closure of wounds than standard care alone. The ESWT device was found to be reliable for treatment of Diabetic foot ulcers.
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