Extracorporeal Shockwave Therapy (ESWT) in the Management of Diabetic Foot Ulcer: A Prospective Randomized Clinical Trial

Diabetic foot ulcer (DFU) is the most common cause of prolonged hospitalization with a high cost of care due to unsatisfactory outcomes with the current mode of therapy. Extracorporeal shockwave therapy (ESWT) is a new technology in the care of nonhealing wounds. The study's main objective was to compare the healing parameters of DFUs between patients undergoing the standard of care (SOC) alone and ESWT + SOC. The secondary objective was to assess inflammatory markers in both study groups. The study was designed as a single-center, randomized trial to provide evidence on the effects of ESWT on DFU healing. Informed consent was obtained from all participants before enrolment. Forty-eight participants were recruited, enrolled, and randomly allocated into the 2 study groups. Twenty-five patients were allocated to the ESWT + SOC group, and 23 patients were allocated into the SOC-only group for a treatment period of 6 weeks. The univariate binary analysis showed more patients with healed DFU in the ESWT + SOC group than the SOC-only group at 6 weeks, though the difference did not reach statistical significance (OR = 3.2, p = .07). The adjusted multivariate binary analysis confirmed this finding; however, the effect size did not reach statistical significance at 6 weeks (OR = 3.9, p = .08). The level of circulating inflammatory markers was similar in both groups of patients. It is the author's opinion that there is a potential benefit of ESWT on diabetic wound healing with further research warranted to determine its role in treatment of DFU. A larger trial with a more extended treatment period is, however, needed to substantiate our findings.