Efficacy of shock wave therapy on chronic diabetic foot ulcer: A single-blinded randomized controlled clinical trial

Objective: This study was conducted to evaluate the efficacy of extracorporeal shock wave therapy (ESWT) on the healing rate, wound surface area and wound bed preparation in chronic diabetic foot ulcers (DFU). Methods: Thirty eight patients with 45 chronic DFU were randomly assigned into; the ESWT-group (19 patients/24 ulcers) and the control-group (19 patients/21 ulcers). Blinded therapist measured wound surface area (WSA), the percentage of reduction in the WSA, rate of healing and wound bed preparation at baseline, after the end of the interventions (W8), and at 20-week follow-up (W20). The ESWT group received shock wave therapy twice per week for a total of eight treatments. Each ulcer was received ESWT at a frequency of 100 pulse/cm(2), and energy flux density of 0.11 mJ/cm(2). All patients received standardized wound care consisting of debridement, blood-glucose control agents, and footwear modification for pressure reduction. Results: The overall clinical results showed completely healed ulcers in 33.3% and 54% in ESWT-groups and 14.28% and 28.5% in the control group after intervention (W8), and at follow-up (W20) respectively. The average healing time was significantly lower (64.5 +/- 8.06 days vs 81.17 +/- 4.35 days, p < 0.05) in the ESWT-group compared with the control group. Conclusion: ESWT-treated ulcers had a significant reduction in wound size and median time required for ulcer healing, with no adverse reactions. So, the ESWT is advocated as an adjunctive therapy in chronic diabetic wound. (C) 2014 Elsevier Ireland Ltd. All rights reserved.