A Non-invasive Focused Extracorporeal Shock Wave Therapy System Promotes Increased Tissue Oxygen Saturation in Chronic Wounds in Persons with Diabetes

Diabetes affects 30.3 million Americans and is on the rise. Chronic lower extremity ulceration in patients with diabetes is a common complication that can lead to major morbidity and mortality if not addressed expeditiously. Despite numerous advances in wound care and healing over the past two decades, these ulcerations continue to pose a significant clinical problem. This case series aimed to evaluate the effectiveness of focused extracorporeal shock wave therapy (F-ESWT) administered via a pulsed acoustic cellular expression system in enhancing localized wound tissue oxygenation and perfusion in chronic wounds. Fifteen subjects with a history of diabetes and a chronic wound of the foot or ankle that had failed to achieve wound area reduction of 50% or greater after at least 4 weeks of standard of care treatment underwent four weekly treatments of F-ESWT administered via a pulsed acoustic cellular expression system. Near-infrared spectroscopy (NIRS) was used to determine the effectiveness of F-ESWT on tissue oxygen saturation within the wound bed. All subjects demonstrated a statistically significant increase in tissue oxygen saturation within the wound bed as well as a decrease in wound area. Seven wounds healed. Results of this case study suggest that F-ESWT promotes increased tissue oxygenation within the wound bed and neovascularization, potentially facilitating accelerated wound resolution of chronic lower extremity ulcerations in patients with diabetes.