158. Quality Of Life Outcomes in Patients With Diabetic Foot Ulcers Treated With High-energy Acoustic Shockwaves (Sanuwave): Results From a Randomized Clinical Trial

PURPOSE: Diabetic foot ulcers (DFUs) severely impact quality of life (QoL). High-energy acoustic shockwave therapy (HEAST) using the dermaPACE System may enhance wound healing and improve QoL. This study evaluates QoL outcomes with different HEAST dosage regimens in DFU patients. METHODS: In a randomized clinical trial, 36 patients with DFUs were assigned to three groups receiving low, medium, or high dosages of shockwaves. QoL was assessed using the Diabetic Foot Syndrome (DFS) questionnaire at baseline, mid-treatment, and post-treatment. Changes in QoL were analyzed using repeated measures ANOVA. RESULTS: Patients in Group 1, who received the lowest number of shockwave pulses, demonstrated the most significant improvements in QoL, with the lowest DFS scores across all domains. “Super-responders,” achieving a 90% or greater reduction in wound size, showed the greatest QoL improvements, particularly in physical health and treatment burden domains. Conversely, “normal responders,” with less than 75% wound reduction, exhibited the least improvement, with higher and more variable DFS scores. No significant differences were found between treatment groups in overall changes, though trends favored less intensive regimens. CONCLUSION: HEAST via the dermaPACE System improves QoL in DFU patients, particularly with lower dosage regimens. These findings suggest that a reduced dosage may optimize patient-reported outcomes, making it a viable option for DFU management.