Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers: A Systematic Review and Meta-Analysis

Background Diabetes mellitus is one of the most common chronic diseases worldwide. Diabetic foot ulcers (DFUs) occur in over 10% of diabetic patients and are associated with high morbidity. Clinical trials have shown benefit from extracorporeal shockwave therapy (ESWT) in a DFU healing. This systematic review aims to assess the currently available evidence examining the efficacy of ESWT on healing of DFU. Methods Electronic databases including PubMed, Ovid MEDLINE, Web of Science, Embase, CINAHL Plus, Cochrane Central Registry of Controlled Trials, and Clinical Trials Registry were searched up to November 2017 for terms related to ESWT in DFU. Articles were identified, and data were extracted by 2 independent reviewers onto Review Manager 5.3 software. Results This review included 5 trials of 255 patients published between 2009 and 2016. Three studies compared ESWT to standard wound care, and 2 studies compared ESWT to hyperbaric oxygen therapy (HBOT). All studies contained unclear to high risk of bias assessed by the Cochrane Risk of Bias Tool. ESWT was superior to standard wound care at complete wound healing (odds ratio [OR] 2.66 95% confidence interval [CI] 1.03, 6.87, I2 0%) and time to healing (64.5 ± 8.06 days versus 81.17 ± 4.35 days). DFU healing improved more with ESWT than HBOT (OR 2.45 95% CI 1.07, 5.61 I2 28%). There was variable evidence of effect on the blood flow perfusion rate. Infection rate and amputation rate were not reported. Conclusions This systematic review concludes that ESWT has the potential to improve healing in DFUs, although there is, as yet, insufficient evidence to justify its use in routine clinical practice. The meta-analysis has a high risk of bias and is unlikely to reflect true effect size because of problematic risk of bias in included studies. This review highlights the variable quality of methodology of trials and dosing of shockwave therapy and the need for robust adequately powered research into this promising therapy. Diabetes mellitus is one of the most common chronic diseases worldwide. Diabetic foot ulcers (DFUs) occur in over 10% of diabetic patients and are associated with high morbidity. Clinical trials have shown benefit from extracorporeal shockwave therapy (ESWT) in a DFU healing. This systematic review aims to assess the currently available evidence examining the efficacy of ESWT on healing of DFU. Electronic databases including PubMed, Ovid MEDLINE, Web of Science, Embase, CINAHL Plus, Cochrane Central Registry of Controlled Trials, and Clinical Trials Registry were searched up to November 2017 for terms related to ESWT in DFU. Articles were identified, and data were extracted by 2 independent reviewers onto Review Manager 5.3 software. This review included 5 trials of 255 patients published between 2009 and 2016. Three studies compared ESWT to standard wound care, and 2 studies compared ESWT to hyperbaric oxygen therapy (HBOT). All studies contained unclear to high risk of bias assessed by the Cochrane Risk of Bias Tool. ESWT was superior to standard wound care at complete wound healing (odds ratio [OR] 2.66 95% confidence interval [CI] 1.03, 6.87, I2 0%) and time to healing (64.5 ± 8.06 days versus 81.17 ± 4.35 days). DFU healing improved more with ESWT than HBOT (OR 2.45 95% CI 1.07, 5.61 I2 28%). There was variable evidence of effect on the blood flow perfusion rate. Infection rate and amputation rate were not reported. This systematic review concludes that ESWT has the potential to improve healing in DFUs, although there is, as yet, insufficient evidence to justify its use in routine clinical practice. The meta-analysis has a high risk of bias and is unlikely to reflect true effect size because of problematic risk of bias in included studies. This review highlights the variable quality of methodology of trials and dosing of shockwave therapy and the need for robust adequately powered research into this promising therapy.