The Effects of High Energy Acoustic Shock Wave Therapy on Local Skin Perfusion and DFUs

Inclusion Criteria: 1. Is male or female ≥22 years of age at Visit 1; 2. Wagnergrade 1 or 2 DFU; 3. In the leg with the target ulcer has an ABI \> 0.70 and \< 1.20 OR if the ABI is \>1.20 has a toe pressure \>50 mmHg at Visit 1 4. Has only one diabetic foot ulcer that is located on the plantar surface of the forefoot that has persisted a minimum of 30 days prior to the first visit. 5. Has Type I or Type II Diabetes Mellitus; 6. HbA1c \< 12% at Visit 1; 7. Patient is willing to comply with all study requirements and treatment visits. 8. Patient is willing to comply with off-loading directions. 9. Patient is willing to comply with offloading instructions Exclusion Criteria: * Potential subjects who meet any of the following criteria will be excluded from participating in the study. A subject who: 1. Is female and is currently pregnant or plans to become pregnant during the study;=, or is a female who is nursing aor actively lactating; 2. Known or suspected systemic infection; 3. Enrolled in another investigational study; 4. Has received growth factor therapy (e.g., autologous platelet-rich plasma, stem cell therapy, becaplermin, cell therapy, dermal substitute, amniotic tissue, extracellular matrix) within 30 days of study enrollment; 5. Subject is currently receiving or has received radiation or chemotherapy within 3 months of study enrollment; 6. Unable to tolerate offloading footwear or total contact casting (TCC); 7. Has active cellulitis either at the site of, or in the surrounding area of, the target ulcer at Visit 1 or 2; 8. Has active Charcot foot at Visit 1 or 2; 9. Has osteomyelitis in the foot or ankle on which the target ulcer is located at Visit 1 or 2