Inclusion Criteria:  Type 1 or Type 2 diabetes mellitus An open DFU / wound of any size (including those requiring debridement in operation room or clinic setting) with or without a secondary fungal infection ≥ 18 years of age Treatment naïve or treatment failure with oral antibiotics to current wound infection  Exclusion Criteria:  Patients who present with untreated or on active-treatment for osteomyelitis, exposed bone, or have a life-threatening need of immediate surgery. Patients who are allergic to any components of the investigated product. Patients who have ≥ 15 shoe size Patients who have received IV antibiotics within the past 30 days Patients with HgbA1C > 14 Patients on active cancer treatment Patients needing re-vascularization of the affected area but did not receive treatment. Patients diagnosed with HIV/AIDs Patients unable or unwilling to obtain and wear off-loading footwear