Diabetic foot ulcer treatment with focused shockwave therapy: Two multicentre, prospective, controlled, double-blinded, randomised phase III clinical trials

Objective: To investigate the efficacy of focused extracorporeal shockwave therapy (ESWT) as an adjunctive treatment for neuropathic diabetic foot ulcers (DFU) (1A or 2A on the University of Texas grading scheme), compared with sham treatment. Method: We performed two multicentre, randomised, sham-controlled, double-blinded, phase III clinical trials using focused ESWT compared with sham examining DFUs that did not reduce in volume by ≥50% over 2 weeks' standard treatment immediately prior to randomisation. Patients were enrolled into the trials and randomised for either standard care and focused ESWT (pulsed acoustic cellular expression. dermaPACE System, SANUWAVE Health Inc.) active therapy, or standard care and sham therapy. Both active and sham therapy were administered four times in 2 weeks in study 1 and a maximum of eight times over 12 weeks in study 2. Standard care continued in both studies throughout the 12-week treatment phase. The proportion of DFUs that closed completely by 12, 20 and 24 weeks was measured. Results: The two studies evaluated 336 patients; 172 patients treated with active therapy and 164 managed with a sham device. The demographic characteristics of patients in the two arms of both studies were balanced and statistical comparison of the two studies justified pooling datasets for analysis. 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. At 12 weeks the active therapy arm trended to significance (22.7% versus 18.3%). Conclusion: The outcome of these two trials suggests that ESWT is an effective therapeutic modality in combination with standard care for neuropathic DFU that do not respond to standard care alone. Declaration of interest: PM is a member of the SANUWAVE Scientific Advisory Board. Both studies were funded by SANUWAVE. SANUWAVE provided the basic outline and supporting clinical basis; hired consultants (medical, statistical, regulatory); and wrote the protocol with medical advisory consultants, adding review and comment. Independent, external statisticians and regulatory consultants analysed the data.